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Dose-response Study to Evaluate Safety, Efficacy, and Pharmacokinetics of PF-00217830 Compared With Placebo in Acute Exacerbation of Schizophrenia

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00580125
Collaborator
(none)
164
Enrollment
26
Locations
5
Arms
10
Duration (Months)
6.3
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is demonstrate efficacy and a dose-response in the treatment of acute exacerbation of schizophrenia in comparison to placebo.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
164 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multicenter, Double-Blind, Randomized, Fixed Dose, Parallel Group, 3-Week Inpatient Treatment Study To Evaluate The Dose-Response Relationship, Safety, Efficacy, And Pharmacokinetics Of PF-00217830 Compared With Placebo, Using Aripiprazole As A Positive Control, In The Treatment Of Acute Exacerbation Of Schizophrenia
Study Start Date :
Nov 1, 2007
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: A2

Drug: PF-00217830
PF-00217830 5 mg, oral capsule, once daily for 21 days
Placebo Comparator: A5

Other: Placebo
Placebo, oral capsule, once daily for 21 days
Active Comparator: A4

Drug: Aripiprazole
Aripiprazole 15 mg, oral capsule, once daily for 21 days
Other Names:
  • Abilify

    		•
    Experimental: A3

    Drug: PF-00217830
    PF-00217830 15 mg, oral capsule, once daily for 21 days
    Experimental: A1

    Drug: PF-00217830
    PF-00217830 2 mg, oral capsule, once daily for 21 days

    Outcome Measures

    Primary Outcome Measures

    1. Clinical laboratory (Screening, Days 1, 7, 14, 21 and Followup); Fasting insulin, HDL, LDL, HbA1c , prolactin, ACTH, and cortisol (Days 1 and 21). [5 weeks]

    2. Physical examination (Screening, Days 1 and 21), neurological examination (Days 1 and 21), and ECG (Screening, Days 1, 7, 14, 20, 21 and Followup). [5 weeks]

    3. Positive and Negative Symptom Scale (PANSS) total score. [Screening, Day 1, 3, 7, 14 and 21]

    4. Adverse events (Daily), weight (Screening, Days 1, and 21) and girth (Days 1 and 21), vital signs (Screening, Days 1, 3, 7, 14, 21 and Followup), [5 weeks]

    5. Extrapyramidal Symptom Rating Scale (Screening, Days 1, 3, 7, 14 and 21) and the Stanford Sleepiness Scale (Days 1, 3, 7, 14 and 21). [4 weeks]

    Secondary Outcome Measures

    1. PANSS-derived Marder factor scores (positive, negative, disorganized thought, hostility/excitement, anxiety/depression) [Screening, Day 1, 3, 7, 14 and 21]

    2. PANSS positive, negative, and general psychopathology subscales [Screening, Day 1, 3, 7, 14 and 21]

    3. Clinical Global Impression Scale-S (severity), and Clinical Global Impression Scale-I (improvement) [Screening and Days 1, 3, 7, 14 and 21]

    4. NOSIE-30 subscales (irritability, manifest psychosis, personal neatness, retardation, social competence, and social interest) and the GAF. [Days 1 and 21]

    5. Treatment Satisfaction Questionnaire for Medication (TSQM) [Day 21]

    6. Pharmacokinetics [Days 7, 14, 20, 21, before discharge and Followup]

    7. PANSS-derived BPRS core psychosis items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) [Screening and Days 1, 3, 7, 14 and 21]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    Key inclusion criteria include:

    • Have a current diagnosis of schizophrenia.

    • Increase in symptoms over the past 2-4 weeks.

    • Willing to remain inpatients for the duration of the trial.

    Exclusion Criteria:

    • Subjects with a current DSM-IV axis I diagnosis other than schizophrenia

    • Subjects who meet the DSM-IV criteria for psychoactive substance abuse and dependence

    • Subjects with a history of treatment resistant schizophrenia

    • Females of childbearing potential

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Garden Grove California United States 92845
    2 Pfizer Investigational Site Torrance California United States 90502
    3 Pfizer Investigational Site Washington District of Columbia United States 20016
    4 Pfizer Investigational Site Detroit Michigan United States 48201
    5 Pfizer Investigational Site Bridgeton Missouri United States 63044-2588
    6 Pfizer Investigational Site Florissant Missouri United States 63033
    7 Pfizer Investigational Site St. Charles Missouri United States 63304
    8 Pfizer Investigational Site Brooklyn New York United States 11203
    9 Pfizer Investigational Site Bangalore Karnataka India 560 034
    10 Pfizer Investigational Site Mangalore Karnataka India 575001
    11 Pfizer Investigational Site Udupi Karnataka India 576 102
    12 Pfizer Investigational Site Pune Maharashtra India 411 004
    13 Pfizer Investigational Site Pune India 411 030
    14 Pfizer Investigational Site Gatchina district Leningrad region Russian Federation 188357
    15 Pfizer Investigational Site Khotkovo Russian Federation 141371
    16 Pfizer Investigational Site Moscow Russian Federation 115522
    17 Pfizer Investigational Site St Petersburg Russian Federation 190121
    18 Pfizer Investigational Site St. Petersburg Russian Federation 194214
    19 Pfizer Investigational Site Simferopol Crimea Ukraine 95006
    20 Pfizer Investigational Site Dnipropetrovsk Ukraine 49115
    21 Pfizer Investigational Site Donetsk Ukraine 83037
    22 Pfizer Investigational Site Kharkiv Ukraine 61018
    23 Pfizer Investigational Site Kharkiv Ukraine 61068
    24 Pfizer Investigational Site Kiev Ukraine 02660
    25 Pfizer Investigational Site Kyiv Ukraine 01030
    26 Pfizer Investigational Site Lugansk Ukraine 91045

    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:
    NCT00580125
    Other Study ID Numbers:
    • A7251006
    First Posted:
    Dec 24, 2007
    Last Update Posted:
    Apr 18, 2012
    Last Verified:
    Jan 1, 2011
    Additional relevant MeSH terms:
    Schizophrenia
    Aripiprazole

    Study Results

    No Results Posted as of Apr 18, 2012