Clincosm LogoSign in Get a demo

An Inpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Treatment Of Acute Exacerbation Of Schizophrenia

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01175135
Collaborator
(none)
259
Enrollment
46
Locations
4
Arms
10
Actual Duration (Months)
5.6
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of acute exacerbation of schizophrenia during a 4-week inpatient treatment period. The study will use the Positive and Negative Syndrome Scale (PANSS) to measure change in symptoms for PF-02545920 compared to risperidone and placebo treatment.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
259 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multicenter, Double-blind, Randomized, Parallel Group, 4-week Inpatient Study To Evaluate The Safety And Efficacy Of Two Fixed Doses Of Pf-02545920 Compared To Placebo In The Treatment Of Acute Exacerbation Of Schizophrenia Using Risperidone As An Active Control
Actual Study Start Date :
Oct 1, 2010
Actual Primary Completion Date :
Aug 1, 2011
Actual Study Completion Date :
Aug 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: PF-02545920 5 mg

Drug: PF-02545920
5 mg tablet every 12 hours for 28 days
Experimental: PF-02545920 15 mg

Drug: PF-02545920
15 mg tablet every 12 hours for 28 days
Placebo Comparator: Placebo

Drug: Placebo
One tablet/capsule every 12 hours for 28 days
Active Comparator: Risperidone 3 mg

Drug: Risperidone
3 mg capsule every 12 hours for 28 days
Other Names:
  • Risperdal

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 [Baseline, Week 4]

      PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.

    2. Proportion of Participants With Dystonia Adverse Events [Baseline up to end of study (7 to 10 days after administration of last dose of study medication)]

      Participants were assessed for presence of symptoms for any one of the following: dystonia, oromandibular dystonia, and oculogyric crisis.

    Secondary Outcome Measures

    1. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 [Baseline, Week 4]

      PANSS - positive, negative, and general subscales assesses positive, negative and general psychopathological symptoms associated with schizophrenia respectively. Seven (7) items each make up the positive scale (for example; delusions, conceptual disorganization, and hallucinatory behavior) and negative scale (for example; blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal) and 16 items make up the general scale (for example; somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, pre-occupation). Each item is rated on a 7-point Likert scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total scores range for positive as well as negative subscale is 7 to 49 and for general subscale is 16 to 112; higher subscale score indicates greater severity.

    2. Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4 [Baseline, Week 4]

      CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state. Clinician responded to a question "Considering your total clinical experience with this particular population, how mentally ill is your patient at this time?" on the following scores: 1 (normal - not ill at all), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most severely ill participants). Higher score = more affected.

    3. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 [Baseline, Week 4]

      PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). PANSS Marder positive symptoms subscale consists of 8 items with total score equal to sum of 8 items ranging from 8-56; Marder negative symptoms subscale and Marder disorganized thoughts (Dis. Thought) subscale, each consists of 7 items with total score equal to sum of 7 items each, ranging from 7-49, Marder uncontrolled hostility/excitement (Uncon. Hos/Exc) subscale and Marder anxiety/depression (Anx/Dep) subscale, each consists of 4 items with total score equal to sum of 4 items each ranging from 4-28. Higher subscale score indicates greater severity.

    4. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Derived Brief Psychiatric Rating Scale (BPRS) Core Score at Week 4 [Baseline, Week 4]

      PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. PANSS derived BPRS is an 18-item clinician rated scale which assesses symptoms such as hostility, suspiciousness, hallucinations, grandiosity, and a number of other psychiatric symptoms. Items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. BPRS core score consists of 4 items (Conceptual disorganization, Hallucinatory behavior, Suspiciousness/persecution, Unusual thought content) with total score equal to sum of the 4 items, ranging from 4 to 28, with higher score indicating greater severity.

    5. Clinical Global Impression - Improvement (CGI-I) Score [Week 4]

      CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: "Compared to your subject's condition at the beginning of treatment, how much has your subject changed?" Compared to Baseline (Day 1), improvement was defined as score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.

    6. Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 4 [Baseline, Week 4]

      GAF is a 100-point, clinician rated single item scale that rates the severity of illness-related impairment in psychological, social and occupational functioning of participants on a hypothetical continuum of mental illness to mental health. The scale values range from 1 to 100 with lower score indicating greater severity of illness and is divided into 10 equal intervals (descriptors): from 1-10 (persistent danger of hurting self - serious suicidal acting with clear expectations of death) to 91-100 (superior functioning - no symptoms). Each descriptor has a nine-point range to allow for some variability of severity within the descriptor.

    7. Treatment Satisfaction Questionnaire for Medication (TSQM) Score [Week 4]

      TSQM assesses the participant's level of satisfaction with study medication. It consists of a 14-item questionnaire which comprises of 3 specific scales (effectiveness, side effects, convenience) and 1 global satisfaction scale. Effectiveness, convenience and global satisfaction scale are rated on a 7-point scale (0= Extremely Dissatisfied, 1= Very Dissatisfied, 2= Dissatisfied, 3= Somewhat Satisfied, 4= Satisfied, 5= Very Satisfied, 6= Extremely Satisfied) and side effects are rated on a 5-point scale (0= Extremely Dissatisfied, 1=Very Dissatisfied, 2= Somewhat Dissatisfied, 3= Slightly Dissatisfied, 4= Not at all Dissatisfied). Scale scores are transformed into scores ranging from 0 to 100, with a higher score indicating more satisfaction.

    8. Change From Baseline in Body Weight at Week 4 [Baseline, Week 4]

    9. Change From Baseline in Abdominal Girth at Week 4 [Baseline, Week 4]

    10. Number of Participants With Clinically Significant Findings in Vital Signs and Electrocardiogram (ECG) [Baseline up to end of study (7 to 10 days after administration of last dose of study medication)]

      Clinically significant findings based on investigator's discretion were assessed in vital sign parameters (including pulse rate, blood pressure and body temperature) and ECG parameters (including respiratory rate, heart rate, PR interval, QRS interval, QT interval, QT corrected using Bazett's correction [QTcB] interval, and QT corrected using Fridericia's correction [QTcF]).

    11. Number of Participants With Clinically Significant Changes in Physical Examinations [Screening, Week 4]

      Clinically significant findings in physical examinations based on investigator's discretion were assessed. Screening was the 7 day time (from Day -8 to Day -2) before dosing on Day 1. Number of participants with clinically significant changes in physical examinations compared to screening was assessed.

    12. Number of Participants With Laboratory Test Abnormalities [Screening up to end of study (7 to 10 days after administration of last dose of study medication)]

      Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count: less than(<) 0.8*lower limit of normal (LLN); mean corpuscular volume; mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration: <0.9*LLN,>1.1*upper limit of normal (ULN); platelets: <0.5*LLN,>1.75*ULN, white blood cell count: <0.6*LLN, >1.5*ULN; lymphocytes, total neutrophils: <0.8*LLN, >1.2*ULN; eosinophils, basophils, monocytes: >1.2*ULN; coagulation: activated partial thromboplastin time, prothrombin, prothrombin international ratio: >1.1*ULN; liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN)

    13. Number of Participants With Abnormal White Blood Cell (WBC) Count and Absolute Neutrophil Count (ANC) [Day 1 up to Week 4]

      Pre-defined criteria was established for WBC Count (less than 0.6 times the lower limit of normal) and absolute neutrophil count (less than 0.8 times the lower limit of normal) to define the values that would be identified as abnormal.

    14. Number of Participants With Clinically Significant Laboratory Test Abnormalities for Fasting Insulin, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Cholesterol, Triglycerides, Hemoglobin Type A1c (HbA1c) and Prolactin [Day 1 up to Week 4]

      Clinically significant findings based on investigator's discretion were assessed in laboratory parameters (including fasting insulin, high-density lipoprotein [HDL], low-density lipoprotein [LDL], Cholesterol, Triglycerides, glycosylated hemoglobin type A1c [HbA1c] and Prolactin).

    15. Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 [Baseline, Week 4]

      ESRS-A is a clinician rated scale consisting of 24 items to assess severity of extra-pyramidal symptoms for following parameters: parkinsonism (10 items), dystonia (6 items), dyskinesia (6 items) and akathisia (2 items). Each item is scored on a 6-point Likert scale (0=absent, 1=minimal, 2=mild, 3=moderate, 4=severe, 5=extreme). Total score for a parameter is average of individual item scores included under the parameter, ranging from 0 to 5, with higher score = more affected.

    16. Change From Baseline in Movement Disorder Burden Score for Dystonia (MDBS-D) at Week 4 [Baseline, Week 4]

      MDBS-D score reflects the numbers and durations of movement disorder adverse events for dystonia, the severity of the events, required treatment, and the total number of days the participant received study treatment. MDBS-D score = (S * D * C)/TTD; where S= Movement Disorder Severity Score for Dystonia (possible values: 1 [mild]; 2 [moderate]; 3 [severe]), D=adverse event duration (in days), C=concomitant medication factor (C=1.5 if an anti-cholinergic or beta blocker is used for the treatment of a movement disorder; C=1 if no concomitant medication is used), TTD=total treatment days for the participant. Value for MDBS score may range from zero to infinity. A higher MDBS-D score indicates a greater movement disorder adverse event liability compared to baseline.

    17. Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) [Baseline, Week 1, 2, 3, 4, Follow-up (FU) (7 to 10 days after administration of last dose of study medication)]

      Data relevant to the assessment of suicidality is mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) event codes. C-SSRS assesses whether participant experiences following: suicide attempt (Event code 2) (Response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (Event code 3) ("Yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), suicidal ideation (Event code 4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior"). Number of participants with "Yes" response for above mentioned categories are assessed. Baseline is defined as the Week 0 measurement.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of schizophrenia with acute exacerbation of illness

    • The current acute exacerbation of schizophrenia must be less than 4 weeks duration prior to the initial evaluation.

    Exclusion Criteria:

    • Subjects with evidence or history of clinically significant uncontrolled medical illness

    • Subjects with a current diagnosis of schizoaffective disorder, major depression, bipolar disorder, or obsessive compulsive disorder.

    • Subjects who meet Diagnostic and Statistical Manual-IV (DSM-IV)defined diagnostic criteria for psychoactive substance dependence (excluding nicotine dependence) within 12 months of screening or DSM-IV defined substance abuse within 3 months prior to screening.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 K & S Professional Research Services, LLC Little Rock Arkansas United States 72201
    2 Leisure Court Center Anaheim California United States 92801
    3 Early Phase Investigational Center Escondido California United States 92025
    4 Synergy Clinical Research Center of Escondido Escondido California United States 92025
    5 Collaborative Neuroscience Network, Inc. Garden Grove California United States 92845
    6 Ocean View Psychiatric Health Facility Long Beach California United States 90806
    7 Long Beach VA Healthcare System Long Beach California United States 90822
    8 University of California Irvine Medical Center Orange California United States 92868
    9 California Clinical Trials Medical Group Paramount California United States 90723
    10 LaPaz Geropsychiatric Center Paramount California United States 90723
    11 Sharp Mesa Vista Hospital San Diego California United States 92123
    12 Neuropsychiatric Research Center of Orange County Santa Ana California United States 92701
    13 Collaborative Neuroscience Network, Inc. Torrance California United States 90502
    14 Del Amo Hospital Torrance California United States 90505
    15 Comprehensive Neuroscience, Incorporated Washington District of Columbia United States 20016
    16 Florida Clinical Research Center, LLC Bradenton Florida United States 34208
    17 Florida Clinical Research Center, LLC Maitland Florida United States 32751
    18 Lakeside Behavioral Healthcare Orlando Florida United States 32810
    19 Atlanta Center for Medical Research Atlanta Georgia United States 30308
    20 Alexian Brothers Behavioral Health Hospital Hoffman Estates Illinois United States 60169
    21 Alexian Brothers Center for Psychiatric Research Hoffman Estates Illinois United States 60169
    22 Chinmay K. Patel, D.O. Hoffman Estates Illinois United States 60169
    23 Lake Charles Memorial Hospital Lake Charles Louisiana United States 70601
    24 Lake Charles Clinical Trials Lake Charles Louisiana United States 70629
    25 CBH Health, LLC Rockville Maryland United States 20850
    26 St. Louis Clinical Trials, LC Saint Louis Missouri United States 63118
    27 CRI Worldwide, LLC Willingboro New Jersey United States 08046
    28 Lourdes Medical Center of Burlington County Willingboro New Jersey United States 08046
    29 Comprehensive Neuroscience, Inc. Hollis New York United States 11423
    30 CRI Worldwide, LLC Philadelphia Pennsylvania United States 19139
    31 FutureSearch Trials Austin Texas United States 78731
    32 TexasNeuroRehab Center Austin Texas United States 78745
    33 Community Clinical Research Austin Texas United States 78754
    34 InSite Clinical Research DeSoto Texas United States 75115
    35 Bayou City Research, Ltd. Houston Texas United States 77007
    36 Behavioral Hospital - Bellaire Houston Texas United States 77081
    37 Eastside Therapeutic Resource Kirkland Washington United States 98033
    38 Fairfax Hospital Kirkland Washington United States 98034
    39 Zentralinstitut fuer Seelische Gesundheit Mannheim Germany 68159
    40 Municipal Establishment "Dnipropetrovsk Regional Clinical Hospital n.a. Mechnikov" Dnipropetrovsk Ukraine 49005
    41 Municipal Establishment "Dnipropetrovsk Regional Clinical Psychiatric Hospital" Dnipropetrovsk Ukraine 49115
    42 Kyiv City Psychoneurological Hospital #2 Kyiv Ukraine 02660
    43 Kyiv City Clinical Psychoneurological Hospital #1 Kyiv Ukraine 04080
    44 Lugansk Regional Clinical Psychoneurological Hospital Lugansk Ukraine 91045
    45 Poltava Regional Clinical Psychiatric Hospital n.a. O.F. Maltsev Poltava Ukraine 36006
    46 Kherson Regional Psychiatric Hospital, Department #3 Stepanivka, Kherson Ukraine 73488

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT01175135
    Other Study ID Numbers:
    • A8241012
    • 2010-020764-38
    First Posted:
    Aug 4, 2010
    Last Update Posted:
    May 22, 2018
    Last Verified:
    Apr 1, 2018
    Keywords provided by Pfizer
    schizophrenia
    acute exacerbation
    inpatient
    Additional relevant MeSH terms:
    Schizophrenia
    Risperidone

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 2 days during the placebo lead-in phase (before randomization in the study).
    Arm/Group Title PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Arm/Group Description Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days. Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days. Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days. Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
    Period Title: Overall Study
    STARTED 74 74 37 74
    Treated 74 74 36 74
    Analyzed for Efficacy 74 73 34 73
    COMPLETED 58 52 25 60
    NOT COMPLETED 16 22 12 14

    Baseline Characteristics

    Arm/Group Title PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo Total
    Arm/Group Description Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days. Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days. Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days. Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days. Total of all reporting groups
    Overall Participants 74 74 36 74 258
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    43.1
    (11.2)
    41.7
    (10.5)
    41.3
    (10.9)
    41.2
    (10.9)
    41.9
    (10.8)
    Sex: Female, Male (Count of Participants)
    Female
    17
    23%
    14
    18.9%
    11
    30.6%
    18
    24.3%
    60
    23.3%
    Male
    57
    77%
    60
    81.1%
    25
    69.4%
    56
    75.7%
    198
    76.7%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
    Description PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.
    Time Frame Baseline, Week 4

    Outcome Measure Data

    Analysis Population Description
    Full analysis set (FAS) included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.
    Arm/Group Title PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Arm/Group Description Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days. Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days. Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days. Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
    Measure Participants 74 73 34 73
    Baseline
    98.1
    (11.81)
    97.7
    (11.14)
    97.4
    (15.05)
    97.2
    (14.92)
    Change at Week 4
    -15.3
    (15.56)
    -13.8
    (17.93)
    -17.9
    (10.99)
    -12.6
    (15.29)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PF-02545920 5 mg, Placebo
    Comments Mixed effect repeated measures (MMRM) model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2053
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
    Estimated Value -2.21
    Confidence Interval (2-Sided) 80%
    -5.66 to 1.24
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.683
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PF-02545920 15 mg, Placebo
    Comments MMRM model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4024
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.67
    Confidence Interval (2-Sided) 80%
    -4.14 to 2.80
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.698
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Risperidone 3 mg, Placebo
    Comments MMRM model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0090
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -8.24
    Confidence Interval (2-Sided) 80%
    -12.68 to -3.80
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.453
    Estimation Comments
    2. Primary Outcome
    Title Proportion of Participants With Dystonia Adverse Events
    Description Participants were assessed for presence of symptoms for any one of the following: dystonia, oromandibular dystonia, and oculogyric crisis.
    Time Frame Baseline up to end of study (7 to 10 days after administration of last dose of study medication)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who received at least 1 dose of study medication.
    Arm/Group Title PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Arm/Group Description Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days. Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days. Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days. Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
    Measure Participants 74 74 36 74
    Number [proportion of participants]
    0.01
    0%
    0.08
    0.1%
    0.00
    0%
    0.04
    0.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PF-02545920 5 mg, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Proportion
    Estimated Value -0.03
    Confidence Interval (2-Sided) 80%
    -0.07 to 0.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments The adjusted 80% Confidence Interval (CI) equals 88.6% CI, adjusted due to 1 interim look.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PF-02545920 15 mg, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Proportion
    Estimated Value 0.04
    Confidence Interval (2-Sided) 80%
    -0.02 to 0.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments The adjusted 80% CI equals 88.6% CI, adjusted due to 1 interim look.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Risperidone 3 mg, Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Proportion
    Estimated Value -0.04
    Confidence Interval (2-Sided) 80%
    -0.08 to -0.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments The adjusted 80% CI equals 88.6% CI, adjusted due to 1 interim look.
    3. Secondary Outcome
    Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4
    Description PANSS - positive, negative, and general subscales assesses positive, negative and general psychopathological symptoms associated with schizophrenia respectively. Seven (7) items each make up the positive scale (for example; delusions, conceptual disorganization, and hallucinatory behavior) and negative scale (for example; blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal) and 16 items make up the general scale (for example; somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, pre-occupation). Each item is rated on a 7-point Likert scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total scores range for positive as well as negative subscale is 7 to 49 and for general subscale is 16 to 112; higher subscale score indicates greater severity.
    Time Frame Baseline, Week 4

    Outcome Measure Data

    Analysis Population Description
    FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.
    Arm/Group Title PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Arm/Group Description Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days. Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days. Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days. Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
    Measure Participants 74 73 34 73
    Baseline: Positive Score
    26.9
    (4.00)
    26.1
    (3.89)
    26.6
    (4.74)
    26.8
    (4.16)
    Baseline: Negative Score
    23.4
    (4.15)
    23.4
    (4.32)
    24.0
    (5.18)
    23.2
    (5.12)
    Baseline: General Score
    47.9
    (6.67)
    48.2
    (6.43)
    46.8
    (8.25)
    47.2
    (7.73)
    Change at Week 4: Positive Score
    -5.0
    (5.26)
    -4.5
    (5.51)
    -6.7
    (3.84)
    -4.5
    (4.68)
    Change at Week 4: Negative Score
    -2.7
    (4.62)
    -2.2
    (5.09)
    -2.7
    (4.03)
    -1.5
    (3.78)
    Change at Week 4: General Score
    -7.5
    (7.75)
    -7.1
    (8.80)
    -8.6
    (5.85)
    -6.6
    (8.20)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PF-02545920 5 mg, Placebo
    Comments Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3144
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.41
    Confidence Interval (2-Sided) 80%
    -1.50 to 0.68
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.845
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PF-02545920 15 mg, Placebo
    Comments Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5700
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.15
    Confidence Interval (2-Sided) 80%
    -0.95 to 1.25
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.854
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Risperidone 3 mg, Placebo
    Comments Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0034
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -2.99
    Confidence Interval (2-Sided) 80%
    -4.40 to -1.59
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.093
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection PF-02545920 5 mg, Placebo
    Comments Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0942
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.96
    Confidence Interval (2-Sided) 80%
    -1.90 to -0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.730
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection PF-02545920 15 mg, Placebo
    Comments Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2030
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.61
    Confidence Interval (2-Sided) 80%
    -1.56 to 0.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.735
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Risperidone 3 mg, Placebo
    Comments Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0907
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.26
    Confidence Interval (2-Sided) 80%
    -2.48 to -0.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.944
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection PF-02545920 5 mg, Placebo
    Comments General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2904
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.74
    Confidence Interval (2-Sided) 80%
    -2.45 to 0.97
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.330
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection PF-02545920 15 mg, Placebo
    Comments General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4710
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.10
    Confidence Interval (2-Sided) 80%
    -1.82 to 1.62
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.339
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Risperidone 3 mg, Placebo
    Comments General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0172
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -3.66
    Confidence Interval (2-Sided) 80%
    -5.86 to -1.45
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.718
    Estimation Comments
    4. Secondary Outcome
    Title Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4
    Description CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state. Clinician responded to a question "Considering your total clinical experience with this particular population, how mentally ill is your patient at this time?" on the following scores: 1 (normal - not ill at all), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most severely ill participants). Higher score = more affected.
    Time Frame Baseline, Week 4

    Outcome Measure Data

    Analysis Population Description
    FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.
    Arm/Group Title PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Arm/Group Description Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days. Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days. Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days. Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
    Measure Participants 74 73 34 73
    Baseline
    5.0
    (0.56)
    5.0
    (0.49)
    4.9
    (0.67)
    5.0
    (0.58)
    Change at Week 4
    -0.7
    (0.87)
    -0.7
    (1.06)
    -0.8
    (0.78)
    -0.6
    (0.92)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PF-02545920 5 mg, Placebo
    Comments MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1970
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.13
    Confidence Interval (2-Sided) 80%
    -0.33 to 0.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.154
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PF-02545920 15 mg, Placebo
    Comments MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3835
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.05
    Confidence Interval (2-Sided) 80%
    -0.24 to 0.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.154
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Risperidone 3 mg, Placebo
    Comments MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0395
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.35
    Confidence Interval (2-Sided) 80%
    -0.61 to -0.10
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.199
    Estimation Comments
    5. Secondary Outcome
    Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4
    Description PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). PANSS Marder positive symptoms subscale consists of 8 items with total score equal to sum of 8 items ranging from 8-56; Marder negative symptoms subscale and Marder disorganized thoughts (Dis. Thought) subscale, each consists of 7 items with total score equal to sum of 7 items each, ranging from 7-49, Marder uncontrolled hostility/excitement (Uncon. Hos/Exc) subscale and Marder anxiety/depression (Anx/Dep) subscale, each consists of 4 items with total score equal to sum of 4 items each ranging from 4-28. Higher subscale score indicates greater severity.
    Time Frame Baseline, Week 4

    Outcome Measure Data

    Analysis Population Description
    FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.
    Arm/Group Title PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Arm/Group Description Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days. Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days. Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days. Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
    Measure Participants 74 73 34 73
    Baseline: Positive score
    30.9
    (4.51)
    30.6
    (4.12)
    30.3
    (5.45)
    31.0
    (4.68)
    Baseline: Negative Score
    23.0
    (4.43)
    23.3
    (4.99)
    22.9
    (5.04)
    23.0
    (5.06)
    Baseline: Dis. Thought Score
    20.4
    (5.13)
    21.0
    (4.37)
    21.3
    (5.49)
    20.3
    (5.70)
    Baseline: Uncon. Hos/Exc Score
    10.4
    (2.92)
    9.8
    (2.98)
    10.6
    (3.97)
    10.0
    (3.44)
    Baseline: Anx/Dep Score
    13.5
    (2.81)
    13.0
    (3.16)
    12.4
    (3.17)
    12.9
    (2.56)
    Change at Week 4: Positive score
    -5.5
    (5.34)
    -5.0
    (5.56)
    -6.2
    (4.53)
    -4.6
    (5.00)
    Change at Week 4: Negative Score
    -3.0
    (4.99)
    -2.9
    (5.69)
    -2.5
    (4.44)
    -2.3
    (4.91)
    Change at Week 4:Dis. Thought Score
    -2.5
    (3.47)
    -2.3
    (4.39)
    -3.0
    (3.06)
    -1.9
    (3.05)
    Change at Week 4:Uncon.Hos/ExcScore
    -1.2
    (3.31)
    -0.9
    (3.12)
    -2.4
    (2.28)
    -1.0
    (2.95)
    Change at Week 4: Anx/DepScore
    -2.9
    (3.72)
    -2.6
    (3.85)
    -3.8
    (3.31)
    -2.9
    (3.22)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PF-02545920 5 mg, Placebo
    Comments Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1999
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.73
    Confidence Interval (2-Sided) 80%
    -1.84 to 0.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.863
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PF-02545920 15 mg, Placebo
    Comments Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3399
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.36
    Confidence Interval (2-Sided) 80%
    -1.48 to 0.76
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.870
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Risperidone 3 mg, Placebo
    Comments Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0100
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -2.62
    Confidence Interval (2-Sided) 80%
    -4.06 to -1.18
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.117
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection PF-02545920 5 mg, Placebo
    Comments Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1625
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.77
    Confidence Interval (2-Sided) 80%
    -1.77 to 0.23
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.778
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection PF-02545920 15 mg, Placebo
    Comments Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2354
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.57
    Confidence Interval (2-Sided) 80%
    -1.57 to 0.44
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.783
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Risperidone 3 mg, Placebo
    Comments Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2161
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.79
    Confidence Interval (2-Sided) 80%
    -2.08 to 0.50
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.002
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection PF-02545920 5 mg, Placebo
    Comments Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2480
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.43
    Confidence Interval (2-Sided) 80%
    -1.23 to 0.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.627
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection PF-02545920 15 mg, Placebo
    Comments Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4345
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.10
    Confidence Interval (2-Sided) 80%
    -0.92 to 0.71
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.632
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Risperidone 3 mg, Placebo
    Comments Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0346
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.48
    Confidence Interval (2-Sided) 80%
    -2.53 to -0.44
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.813
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection PF-02545920 5 mg, Placebo
    Comments Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4685
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.04
    Confidence Interval (2-Sided) 80%
    -0.68 to 0.60
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.495
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection PF-02545920 15 mg, Placebo
    Comments Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6214
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.15
    Confidence Interval (2-Sided) 80%
    -0.49 to 0.80
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.499
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Risperidone 3 mg, Placebo
    Comments Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0052
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.66
    Confidence Interval (2-Sided) 80%
    -2.48 to -0.84
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.641
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection PF-02545920 5 mg, Placebo
    Comments Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5894
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.12
    Confidence Interval (2-Sided) 80%
    -0.55 to 0.79
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.523
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection PF-02545920 15 mg, Placebo
    Comments Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8155
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.47
    Confidence Interval (2-Sided) 80%
    -0.20 to 1.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.526
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Risperidone 3 mg, Placebo
    Comments Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0069
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.68
    Confidence Interval (2-Sided) 80%
    -2.55 to -0.81
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.677
    Estimation Comments
    6. Secondary Outcome
    Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Derived Brief Psychiatric Rating Scale (BPRS) Core Score at Week 4
    Description PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. PANSS derived BPRS is an 18-item clinician rated scale which assesses symptoms such as hostility, suspiciousness, hallucinations, grandiosity, and a number of other psychiatric symptoms. Items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. BPRS core score consists of 4 items (Conceptual disorganization, Hallucinatory behavior, Suspiciousness/persecution, Unusual thought content) with total score equal to sum of the 4 items, ranging from 4 to 28, with higher score indicating greater severity.
    Time Frame Baseline, Week 4

    Outcome Measure Data

    Analysis Population Description
    FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.
    Arm/Group Title PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Arm/Group Description Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days. Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days. Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days. Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
    Measure Participants 74 73 34 73
    Baseline
    17.4
    (2.74)
    17.3
    (2.32)
    17.2
    (2.77)
    17.3
    (2.39)
    Change at Week 4
    -3.7
    (3.39)
    -3.4
    (3.75)
    -4.7
    (2.99)
    -3.2
    (3.12)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PF-02545920 5 mg, Placebo
    Comments MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2727
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.34
    Confidence Interval (2-Sided) 80%
    -1.06 to 0.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.559
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PF-02545920 15 mg, Placebo
    Comments MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4747
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.04
    Confidence Interval (2-Sided) 80%
    -0.76 to 0.69
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.562
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Risperidone 3 mg, Placebo
    Comments MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0031
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -2.00
    Confidence Interval (2-Sided) 80%
    -2.93 to -1.07
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.723
    Estimation Comments
    7. Secondary Outcome
    Title Clinical Global Impression - Improvement (CGI-I) Score
    Description CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: "Compared to your subject's condition at the beginning of treatment, how much has your subject changed?" Compared to Baseline (Day 1), improvement was defined as score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
    Time Frame Week 4

    Outcome Measure Data

    Analysis Population Description
    FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.
    Arm/Group Title PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Arm/Group Description Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days. Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days. Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days. Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
    Measure Participants 63 58 26 63
    Mean (Standard Deviation) [units on a scale]
    3.1
    (0.98)
    3.3
    (1.35)
    2.7
    (0.89)
    3.2
    (1.05)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PF-02545920 5 mg, Placebo
    Comments MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3598
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.07
    Confidence Interval (2-Sided) 80%
    -0.32 to 0.18
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.196
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PF-02545920 15 mg, Placebo
    Comments MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7275
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.12
    Confidence Interval (2-Sided) 80%
    -0.13 to 0.37
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.198
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Risperidone 3 mg, Placebo
    Comments MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0019
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.75
    Confidence Interval (2-Sided) 80%
    -1.07 to -0.42
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.255
    Estimation Comments
    8. Secondary Outcome
    Title Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 4
    Description GAF is a 100-point, clinician rated single item scale that rates the severity of illness-related impairment in psychological, social and occupational functioning of participants on a hypothetical continuum of mental illness to mental health. The scale values range from 1 to 100 with lower score indicating greater severity of illness and is divided into 10 equal intervals (descriptors): from 1-10 (persistent danger of hurting self - serious suicidal acting with clear expectations of death) to 91-100 (superior functioning - no symptoms). Each descriptor has a nine-point range to allow for some variability of severity within the descriptor.
    Time Frame Baseline, Week 4

    Outcome Measure Data

    Analysis Population Description
    FAS. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
    Arm/Group Title PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Arm/Group Description Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days. Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days. Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days. Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
    Measure Participants 73 71 34 72
    Baseline
    38.4
    (8.31)
    38.5
    (7.82)
    38.7
    (10.58)
    38.2
    (8.78)
    Change at Week 4
    6.3
    (9.08)
    6.9
    (8.92)
    7.7
    (8.45)
    6.3
    (8.14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PF-02545920 5 mg, Placebo
    Comments MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5429
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.16
    Confidence Interval (2-Sided) 80%
    -2.06 to 1.74
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.478
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection PF-02545920 15 mg, Placebo
    Comments MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4354
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.24
    Confidence Interval (2-Sided) 80%
    -1.68 to 2.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.492
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Risperidone 3 mg, Placebo
    Comments MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0930
    Comments Reported p-value was 1-sided.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 2.53
    Confidence Interval (2-Sided) 80%
    0.08 to 4.99
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.907
    Estimation Comments
    9. Secondary Outcome
    Title Treatment Satisfaction Questionnaire for Medication (TSQM) Score
    Description TSQM assesses the participant's level of satisfaction with study medication. It consists of a 14-item questionnaire which comprises of 3 specific scales (effectiveness, side effects, convenience) and 1 global satisfaction scale. Effectiveness, convenience and global satisfaction scale are rated on a 7-point scale (0= Extremely Dissatisfied, 1= Very Dissatisfied, 2= Dissatisfied, 3= Somewhat Satisfied, 4= Satisfied, 5= Very Satisfied, 6= Extremely Satisfied) and side effects are rated on a 5-point scale (0= Extremely Dissatisfied, 1=Very Dissatisfied, 2= Somewhat Dissatisfied, 3= Slightly Dissatisfied, 4= Not at all Dissatisfied). Scale scores are transformed into scores ranging from 0 to 100, with a higher score indicating more satisfaction.
    Time Frame Week 4

    Outcome Measure Data

    Analysis Population Description
    FAS. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
    Arm/Group Title PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Arm/Group Description Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days. Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days. Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days. Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
    Measure Participants 71 70 32 69
    Effectiveness
    53.68
    (24.84)
    51.90
    (24.28)
    63.37
    (24.07)
    53.70
    (19.68)
    Side-Effects
    86.43
    (24.45)
    79.20
    (28.67)
    87.30
    (22.02)
    87.41
    (24.00)
    Convenience
    70.46
    (17.46)
    68.37
    (18.49)
    75.69
    (15.44)
    66.83
    (15.12)
    Global Satisfaction
    56.84
    (28.30)
    51.02
    (27.79)
    66.07
    (23.38)
    49.48
    (24.69)
    10. Secondary Outcome
    Title Change From Baseline in Body Weight at Week 4
    Description
    Time Frame Baseline, Week 4

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
    Arm/Group Title PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Arm/Group Description Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days. Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days. Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days. Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
    Measure Participants 74 72 36 74
    Baseline
    86.1
    (15.06)
    87.5
    (14.46)
    83.9
    (16.99)
    84.3
    (19.31)
    Change at Week 4
    0.18
    (2.23)
    -1.23
    (3.18)
    2.69
    (3.00)
    1.04
    (2.61)
    11. Secondary Outcome
    Title Change From Baseline in Abdominal Girth at Week 4
    Description
    Time Frame Baseline, Week 4

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
    Arm/Group Title PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Arm/Group Description Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days. Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days. Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days. Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
    Measure Participants 74 72 36 72
    Baseline
    96.5
    (12.33)
    97.2
    (13.49)
    95.6
    (13.58)
    93.5
    (16.05)
    Change at Week 4
    0.71
    (5.07)
    0.70
    (5.73)
    3.33
    (4.54)
    0.74
    (4.29)
    12. Secondary Outcome
    Title Number of Participants With Clinically Significant Findings in Vital Signs and Electrocardiogram (ECG)
    Description Clinically significant findings based on investigator's discretion were assessed in vital sign parameters (including pulse rate, blood pressure and body temperature) and ECG parameters (including respiratory rate, heart rate, PR interval, QRS interval, QT interval, QT corrected using Bazett's correction [QTcB] interval, and QT corrected using Fridericia's correction [QTcF]).
    Time Frame Baseline up to end of study (7 to 10 days after administration of last dose of study medication)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who received at least 1 dose of study medication.
    Arm/Group Title PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Arm/Group Description Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days. Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days. Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days. Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
    Measure Participants 74 74 36 74
    Number [participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    13. Secondary Outcome
    Title Number of Participants With Clinically Significant Changes in Physical Examinations
    Description Clinically significant findings in physical examinations based on investigator's discretion were assessed. Screening was the 7 day time (from Day -8 to Day -2) before dosing on Day 1. Number of participants with clinically significant changes in physical examinations compared to screening was assessed.
    Time Frame Screening, Week 4

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who received at least 1 dose of study medication.
    Arm/Group Title PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Arm/Group Description Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days. Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days. Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days. Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
    Measure Participants 74 74 36 74
    Number [participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    14. Secondary Outcome
    Title Number of Participants With Laboratory Test Abnormalities
    Description Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count: less than(<) 0.8*lower limit of normal (LLN); mean corpuscular volume; mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration: <0.9*LLN,>1.1*upper limit of normal (ULN); platelets: <0.5*LLN,>1.75*ULN, white blood cell count: <0.6*LLN, >1.5*ULN; lymphocytes, total neutrophils: <0.8*LLN, >1.2*ULN; eosinophils, basophils, monocytes: >1.2*ULN; coagulation: activated partial thromboplastin time, prothrombin, prothrombin international ratio: >1.1*ULN; liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN)
    Time Frame Screening up to end of study (7 to 10 days after administration of last dose of study medication)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
    Arm/Group Title PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Arm/Group Description Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days. Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days. Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days. Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
    Measure Participants 74 74 35 74
    Number [participants]
    55
    74.3%
    58
    78.4%
    34
    94.4%
    56
    75.7%
    15. Secondary Outcome
    Title Number of Participants With Abnormal White Blood Cell (WBC) Count and Absolute Neutrophil Count (ANC)
    Description Pre-defined criteria was established for WBC Count (less than 0.6 times the lower limit of normal) and absolute neutrophil count (less than 0.8 times the lower limit of normal) to define the values that would be identified as abnormal.
    Time Frame Day 1 up to Week 4

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure
    Arm/Group Title PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Arm/Group Description Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days. Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days. Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days. Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
    Measure Participants 74 74 35 74
    WBC
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ANC
    6
    8.1%
    6
    8.1%
    0
    0%
    8
    10.8%
    16. Secondary Outcome
    Title Number of Participants With Clinically Significant Laboratory Test Abnormalities for Fasting Insulin, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Cholesterol, Triglycerides, Hemoglobin Type A1c (HbA1c) and Prolactin
    Description Clinically significant findings based on investigator's discretion were assessed in laboratory parameters (including fasting insulin, high-density lipoprotein [HDL], low-density lipoprotein [LDL], Cholesterol, Triglycerides, glycosylated hemoglobin type A1c [HbA1c] and Prolactin).
    Time Frame Day 1 up to Week 4

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
    Arm/Group Title PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Arm/Group Description Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days. Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days. Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days. Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
    Measure Participants 74 74 35 74
    Number [participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    17. Secondary Outcome
    Title Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4
    Description ESRS-A is a clinician rated scale consisting of 24 items to assess severity of extra-pyramidal symptoms for following parameters: parkinsonism (10 items), dystonia (6 items), dyskinesia (6 items) and akathisia (2 items). Each item is scored on a 6-point Likert scale (0=absent, 1=minimal, 2=mild, 3=moderate, 4=severe, 5=extreme). Total score for a parameter is average of individual item scores included under the parameter, ranging from 0 to 5, with higher score = more affected.
    Time Frame Baseline, Week 4

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who received at least 1 dose of study medication.
    Arm/Group Title PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Arm/Group Description Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days. Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days. Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days. Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
    Measure Participants 74 74 36 74
    Baseline: Parkinsonism
    0.257
    (1.0476)
    0.500
    (1.5283)
    0.194
    (0.6242)
    0.473
    (1.5809)
    Baseline: Dystonia
    0.095
    (0.5278)
    0.000
    (0.0000)
    0.000
    (0.0000)
    0.027
    (0.1633)
    Baseline: Dyskinesia
    0.122
    (0.4038)
    0.095
    (0.4432)
    0.194
    (0.5767)
    0.135
    (0.5054)
    Baseline: Akathisia
    0.162
    (0.5496)
    0.068
    (0.4778)
    0.111
    (0.6667)
    0.243
    (0.7551)
    Change at Week 4: Parkinsonism
    0.143
    (0.8397)
    0.086
    (1.3414)
    -0.038
    (0.9157)
    -0.190
    (1.4126)
    Change at Week 4: Dystonia
    0.000
    (0.4016)
    0.207
    (1.1044)
    0.000
    (0.0000)
    0.032
    (0.2520)
    Change at Week 4: Dyskinesia
    0.016
    (0.4916)
    0.207
    (1.0884)
    0.038
    (0.4455)
    -0.032
    (0.3578)
    Change at Week 4: Akathisia
    0.032
    (0.6713)
    0.328
    (1.3297)
    0.154
    (1.2866)
    -0.095
    (0.9283)
    18. Secondary Outcome
    Title Change From Baseline in Movement Disorder Burden Score for Dystonia (MDBS-D) at Week 4
    Description MDBS-D score reflects the numbers and durations of movement disorder adverse events for dystonia, the severity of the events, required treatment, and the total number of days the participant received study treatment. MDBS-D score = (S * D * C)/TTD; where S= Movement Disorder Severity Score for Dystonia (possible values: 1 [mild]; 2 [moderate]; 3 [severe]), D=adverse event duration (in days), C=concomitant medication factor (C=1.5 if an anti-cholinergic or beta blocker is used for the treatment of a movement disorder; C=1 if no concomitant medication is used), TTD=total treatment days for the participant. Value for MDBS score may range from zero to infinity. A higher MDBS-D score indicates a greater movement disorder adverse event liability compared to baseline.
    Time Frame Baseline, Week 4

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who received at least 1 dose of study medication.
    Arm/Group Title PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Arm/Group Description Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days. Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days. Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days. Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
    Measure Participants 74 74 36 74
    Mean (Standard Deviation) [units on a scale]
    0.0019
    (0.01648)
    0.0163
    (0.08087)
    0.0000
    (0.00000)
    0.0126
    (0.10349)
    19. Secondary Outcome
    Title Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS)
    Description Data relevant to the assessment of suicidality is mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) event codes. C-SSRS assesses whether participant experiences following: suicide attempt (Event code 2) (Response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (Event code 3) ("Yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), suicidal ideation (Event code 4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior"). Number of participants with "Yes" response for above mentioned categories are assessed. Baseline is defined as the Week 0 measurement.
    Time Frame Baseline, Week 1, 2, 3, 4, Follow-up (FU) (7 to 10 days after administration of last dose of study medication)

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who received at least 1 dose of study medication.
    Arm/Group Title PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Arm/Group Description Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days. Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days. Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days. Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
    Measure Participants 74 74 36 74
    Baseline: Event code 2
    1
    1.4%
    1
    1.4%
    0
    0%
    1
    1.4%
    Baseline: Event code 3
    1
    1.4%
    0
    0%
    0
    0%
    2
    2.7%
    Baseline: Event code 4
    1
    1.4%
    4
    5.4%
    1
    2.8%
    3
    4.1%
    Baseline: Event code 7
    0
    0%
    1
    1.4%
    0
    0%
    0
    0%
    Week 1: Event code 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Week 1: Event code 3
    0
    0%
    1
    1.4%
    0
    0%
    0
    0%
    Week 1: Event code 4
    0
    0%
    4
    5.4%
    0
    0%
    0
    0%
    Week 1: Event code 7
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Week 2: Event code 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Week 2: Event code 3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Week 2: Event code 4
    1
    1.4%
    3
    4.1%
    0
    0%
    1
    1.4%
    Week 2: Event code 7
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Week 3: Event code 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Week 3: Event code 3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Week 3: Event code 4
    0
    0%
    2
    2.7%
    0
    0%
    1
    1.4%
    Week 3: Event code 7
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Week 4: Event code 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Week 4: Event code 3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Week 4: Event code 4
    3
    4.1%
    3
    4.1%
    1
    2.8%
    0
    0%
    Week 4: Event code 7
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    FU: Event code 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    FU: Event code 3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    FU: Event code 4
    1
    1.4%
    0
    0%
    1
    2.8%
    0
    0%
    FU: Event code 7
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
    Arm/Group Title PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Arm/Group Description Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days. Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days. Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days. Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
    All Cause Mortality
    PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/74 (4.1%) 6/74 (8.1%) 2/36 (5.6%) 1/74 (1.4%)
    Cardiac disorders
    Acute myocardial infarction 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    Myocardial rupture 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    General disorders
    Sudden cardiac death 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    Psychiatric disorders
    Homicidal ideation 0/74 (0%) 0/74 (0%) 1/36 (2.8%) 0/74 (0%)
    Psychotic disorder 0/74 (0%) 2/74 (2.7%) 0/36 (0%) 1/74 (1.4%)
    Schizophrenia 1/74 (1.4%) 3/74 (4.1%) 1/36 (2.8%) 0/74 (0%)
    Suicidal ideation 0/74 (0%) 1/74 (1.4%) 1/36 (2.8%) 0/74 (0%)
    Other (Not Including Serious) Adverse Events
    PF-02545920 5 mg PF-02545920 15 mg Risperidone 3 mg Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 53/74 (71.6%) 47/74 (63.5%) 22/36 (61.1%) 51/74 (68.9%)
    Blood and lymphatic system disorders
    Lymphadenopathy 0/74 (0%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Neutropenia 5/74 (6.8%) 2/74 (2.7%) 1/36 (2.8%) 4/74 (5.4%)
    Cardiac disorders
    Palpitations 0/74 (0%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Tachycardia 0/74 (0%) 3/74 (4.1%) 1/36 (2.8%) 0/74 (0%)
    Ear and labyrinth disorders
    Cerumen impaction 0/74 (0%) 0/74 (0%) 1/36 (2.8%) 0/74 (0%)
    Ear pain 1/74 (1.4%) 0/74 (0%) 2/36 (5.6%) 1/74 (1.4%)
    Vertigo positional 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    Eye disorders
    Oculogyric crisis 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Vision blurred 1/74 (1.4%) 1/74 (1.4%) 0/36 (0%) 1/74 (1.4%)
    Gastrointestinal disorders
    Abdominal discomfort 2/74 (2.7%) 3/74 (4.1%) 0/36 (0%) 2/74 (2.7%)
    Abdominal pain 0/74 (0%) 1/74 (1.4%) 2/36 (5.6%) 0/74 (0%)
    Abdominal pain upper 2/74 (2.7%) 2/74 (2.7%) 1/36 (2.8%) 0/74 (0%)
    Constipation 8/74 (10.8%) 2/74 (2.7%) 2/36 (5.6%) 6/74 (8.1%)
    Diarrhoea 3/74 (4.1%) 2/74 (2.7%) 1/36 (2.8%) 4/74 (5.4%)
    Dry mouth 1/74 (1.4%) 3/74 (4.1%) 1/36 (2.8%) 2/74 (2.7%)
    Dyspepsia 5/74 (6.8%) 3/74 (4.1%) 3/36 (8.3%) 6/74 (8.1%)
    Flatulence 2/74 (2.7%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    Gastrooesophageal reflux disease 0/74 (0%) 2/74 (2.7%) 0/36 (0%) 2/74 (2.7%)
    Gingival pain 0/74 (0%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Gingivitis 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    Glossodynia 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Lip disorder 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Lip swelling 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Nausea 3/74 (4.1%) 6/74 (8.1%) 3/36 (8.3%) 5/74 (6.8%)
    Salivary hypersecretion 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 2/74 (2.7%)
    Toothache 2/74 (2.7%) 2/74 (2.7%) 1/36 (2.8%) 4/74 (5.4%)
    Vomiting 2/74 (2.7%) 3/74 (4.1%) 2/36 (5.6%) 5/74 (6.8%)
    General disorders
    Chest discomfort 0/74 (0%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Chest pain 1/74 (1.4%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Discomfort 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Fatigue 0/74 (0%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Feeling jittery 0/74 (0%) 0/74 (0%) 1/36 (2.8%) 0/74 (0%)
    Irritability 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Oedema peripheral 0/74 (0%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Pain 1/74 (1.4%) 0/74 (0%) 1/36 (2.8%) 2/74 (2.7%)
    Pyrexia 2/74 (2.7%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    Infections and infestations
    Bronchitis 1/74 (1.4%) 1/74 (1.4%) 0/36 (0%) 1/74 (1.4%)
    Folliculitis 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 1/74 (1.4%)
    Furuncle 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    Infected bites 0/74 (0%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Nasopharyngitis 1/74 (1.4%) 0/74 (0%) 1/36 (2.8%) 0/74 (0%)
    Otitis externa 0/74 (0%) 0/74 (0%) 0/36 (0%) 2/74 (2.7%)
    Otitis media 0/74 (0%) 0/74 (0%) 0/36 (0%) 2/74 (2.7%)
    Pelvic inflammatory disease 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Pneumonia bacterial 0/74 (0%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Rhinitis 0/74 (0%) 0/74 (0%) 1/36 (2.8%) 0/74 (0%)
    Sinusitis 0/74 (0%) 0/74 (0%) 1/36 (2.8%) 0/74 (0%)
    Tinea pedis 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 2/74 (2.7%)
    Tooth abscess 0/74 (0%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Tooth infection 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Upper respiratory tract infection 1/74 (1.4%) 0/74 (0%) 2/36 (5.6%) 2/74 (2.7%)
    Urinary tract infection 0/74 (0%) 2/74 (2.7%) 0/36 (0%) 1/74 (1.4%)
    Viral upper respiratory tract infection 0/74 (0%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Injury, poisoning and procedural complications
    Joint dislocation 0/74 (0%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Lip injury 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Muscle injury 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    Muscle strain 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    Tooth fracture 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    Investigations
    Aspartate aminotransferase increased 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Blood bilirubin increased 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Blood glucose increased 0/74 (0%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Blood insulin increased 0/74 (0%) 0/74 (0%) 1/36 (2.8%) 1/74 (1.4%)
    Blood potassium decreased 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Blood pressure increased 1/74 (1.4%) 2/74 (2.7%) 0/36 (0%) 0/74 (0%)
    Blood uric acid increased 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Weight increased 0/74 (0%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Metabolism and nutrition disorders
    Decreased appetite 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/74 (0%) 2/74 (2.7%) 0/36 (0%) 1/74 (1.4%)
    Back pain 4/74 (5.4%) 2/74 (2.7%) 2/36 (5.6%) 3/74 (4.1%)
    Flank pain 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Groin pain 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Joint stiffness 0/74 (0%) 3/74 (4.1%) 0/36 (0%) 0/74 (0%)
    Joint swelling 0/74 (0%) 0/74 (0%) 1/36 (2.8%) 0/74 (0%)
    Muscle spasms 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 4/74 (5.4%)
    Muscle tightness 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Musculoskeletal pain 2/74 (2.7%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Musculoskeletal stiffness 2/74 (2.7%) 1/74 (1.4%) 1/36 (2.8%) 0/74 (0%)
    Myalgia 1/74 (1.4%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Neck pain 2/74 (2.7%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Nuchal rigidity 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    Pain in extremity 4/74 (5.4%) 1/74 (1.4%) 1/36 (2.8%) 0/74 (0%)
    Nervous system disorders
    Akathisia 6/74 (8.1%) 5/74 (6.8%) 1/36 (2.8%) 1/74 (1.4%)
    Aphonia 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    Cervicobrachial syndrome 0/74 (0%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Dizziness 2/74 (2.7%) 3/74 (4.1%) 0/36 (0%) 4/74 (5.4%)
    Drooling 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    Dysarthria 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 1/74 (1.4%)
    Dyskinesia 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Dystonia 0/74 (0%) 3/74 (4.1%) 0/36 (0%) 1/74 (1.4%)
    Extrapyramidal disorder 2/74 (2.7%) 1/74 (1.4%) 0/36 (0%) 1/74 (1.4%)
    Headache 15/74 (20.3%) 10/74 (13.5%) 9/36 (25%) 11/74 (14.9%)
    Hypoaesthesia 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Lethargy 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    Movement disorder 0/74 (0%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Oromandibular dystonia 1/74 (1.4%) 2/74 (2.7%) 0/36 (0%) 1/74 (1.4%)
    Paraesthesia 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    Parkinsonism 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Restless legs syndrome 1/74 (1.4%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Sedation 3/74 (4.1%) 5/74 (6.8%) 1/36 (2.8%) 3/74 (4.1%)
    Somnolence 2/74 (2.7%) 4/74 (5.4%) 1/36 (2.8%) 2/74 (2.7%)
    Tension headache 0/74 (0%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Tremor 2/74 (2.7%) 2/74 (2.7%) 1/36 (2.8%) 2/74 (2.7%)
    Psychiatric disorders
    Abnormal dreams 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    Aggression 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    Agitation 2/74 (2.7%) 1/74 (1.4%) 0/36 (0%) 1/74 (1.4%)
    Anxiety 2/74 (2.7%) 2/74 (2.7%) 1/36 (2.8%) 1/74 (1.4%)
    Delusion 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Insomnia 4/74 (5.4%) 3/74 (4.1%) 0/36 (0%) 2/74 (2.7%)
    Mental status changes 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Nightmare 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Psychotic disorder 0/74 (0%) 2/74 (2.7%) 0/36 (0%) 0/74 (0%)
    Restlessness 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Schizophrenia 2/74 (2.7%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Suicidal ideation 0/74 (0%) 1/74 (1.4%) 1/36 (2.8%) 0/74 (0%)
    Renal and urinary disorders
    Enuresis 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 1/74 (1.4%)
    Haematuria 0/74 (0%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Nocturia 0/74 (0%) 0/74 (0%) 1/36 (2.8%) 0/74 (0%)
    Pollakiuria 1/74 (1.4%) 0/74 (0%) 1/36 (2.8%) 0/74 (0%)
    Polyuria 0/74 (0%) 0/74 (0%) 1/36 (2.8%) 0/74 (0%)
    Reproductive system and breast disorders
    Dysmenorrhoea 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Erectile dysfunction 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Galactorrhoea 0/74 (0%) 0/74 (0%) 1/36 (2.8%) 0/74 (0%)
    Pruritus genital 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Testicular pain 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Respiratory, thoracic and mediastinal disorders
    Atelectasis 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    Cough 3/74 (4.1%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    Dyspnoea 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    Epistaxis 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Nasal congestion 3/74 (4.1%) 1/74 (1.4%) 1/36 (2.8%) 0/74 (0%)
    Oropharyngeal pain 4/74 (5.4%) 2/74 (2.7%) 1/36 (2.8%) 2/74 (2.7%)
    Respiratory tract congestion 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    Rhinitis allergic 0/74 (0%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Sinus congestion 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    Throat irritation 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Tonsillar inflammation 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Skin and subcutaneous tissue disorders
    Acne 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Dermatitis 0/74 (0%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Dermatitis contact 0/74 (0%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Hyperhidrosis 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 0/74 (0%)
    Pruritus 3/74 (4.1%) 1/74 (1.4%) 0/36 (0%) 1/74 (1.4%)
    Pruritus generalised 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Rash 1/74 (1.4%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Swelling face 0/74 (0%) 0/74 (0%) 1/36 (2.8%) 0/74 (0%)
    Vascular disorders
    Hot flush 0/74 (0%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Hypertension 0/74 (0%) 0/74 (0%) 0/36 (0%) 1/74 (1.4%)
    Hypotension 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)
    Orthostatic hypotension 0/74 (0%) 1/74 (1.4%) 0/36 (0%) 0/74 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

    Results Point of Contact

    Name/Title Pfizer ClinicalTrials.gov Call Center
    Organization Pfizer, Inc.
    Phone 1-800-718-1021
    Email ClinicalTrials.gov_Inquiries@pfizer.com
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT01175135
    Other Study ID Numbers:
    • A8241012
    • 2010-020764-38
    First Posted:
    Aug 4, 2010
    Last Update Posted:
    May 22, 2018
    Last Verified:
    Apr 1, 2018