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6-week Trial of the Efficacy and Safety of Asenapine Compared to Placebo in Participants With an Acute Exacerbation of Schizophrenia (P06124)

Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT01098110
Collaborator
(none)
532
Enrollment
3
Arms
46.7
Actual Duration (Months)

Study Details

Study Description

Brief Summary

A multicenter, randomized, parallel-group, double-blind, fixed dose, 6-week trial of the efficacy and safety of asenapine compared with placebo in participants with an acute exacerbation of schizophrenia.

Condition or Disease Intervention/Treatment Phase
  • Drug: Asenapine 5 mg
  • Drug: Asenapine 10 mg
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
532 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-blind, Fixed-dose, 6-week Trial of the Efficacy and Safety of Asenapine Compared With Placebo in Subjects With an Acute Exacerbation of Schizophrenia (Phase 3)
Actual Study Start Date :
May 25, 2010
Actual Primary Completion Date :
Apr 14, 2014
Actual Study Completion Date :
Apr 14, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Asenapine 5 mg BID

Participants received a 5 mg asenapine fast dissolving tablet twice daily (BID) for 6 weeks.

Drug: Asenapine 5 mg
Asenapine 5 mg fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), on Day 1 only or for 6 weeks.
Other Names:
  • SCH 900274

    		•
    Experimental: Asenapine 10 mg BID

    Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.

    Drug: Asenapine 5 mg
    Asenapine 5 mg fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), on Day 1 only or for 6 weeks.
    Other Names:
  • SCH 900274

    • Drug: Asenapine 10 mg
    Participants receive on Day 2, 10 mg BID of fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), for 6 weeks.
    Other Names:
  • SCH 900274

    		•
    Placebo Comparator: Placebo BID

    Participants received matching placebo BID for 6 weeks.

    Drug: Placebo
    A matching placebo of asenapine sublingual tablet not containing asenapine

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score. [Baseline and Day 42]

      PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score is the sum of the scores for all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. Change from baseline values that are negative represent an improvement in symptoms.

    Secondary Outcome Measures

    1. Change From Baseline in PANSS Positive Symptom Score. [Baseline and Day 42]

      PANSS Positive subscale measures symptoms of schizophrenia and consists of responses to 7 items (P1-P7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Positive subscale sums all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.

    2. Change From Baseline in PANSS Negative Symptom Score. [Baseline and Day 42]

      PANSS Negative subscale measures symptoms of schizophrenia and consists of responses to 7 items (N1-N7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Negative subscale sums all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. . An improvement in symptoms is represented by change from baseline values that are negative.

    3. Change From Baseline in PANSS General Psychopathology Score. [Baseline and Day 42]

      PANSS General Psychopathology subscale measures symptoms of schizophrenia and consists of responses to 16 items (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS General Psychopathology subscale is the sum of the scores for all 16 items and ranges from 16 to 112, with a higher score indicating greater severity of symptoms.. An improvement in symptoms is represented by change from baseline values that are negative.

    4. Change From Baseline in PANSS Marder Factor Positive Symptom Score. [Baseline and Day 42]

      PANSS Marder Factor Positive symptom score measures symptoms of schizophrenia and consists of responses to 8 items (P1,P3,P5,P6,N7,G1,G9,G12). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Positive symptom score is the sum of the scores for all 8 items and ranges from 8 to 56, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.

    5. Change From Baseline in PANSS Marder Factor Negative Symptom Score. [Baseline and Day 42]

      PANSS Marder Factor Negative symptom score measures symptoms of schizophrenia and consists of responses to 7 items (N1,N2,N3,N4,N6,G7,G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Negative symptom score is the sum of the scores for all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.

    6. Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score. [Baseline and Day 42]

      PANSS Marder Factor Disorganized Thought symptom score measures symptoms of schizophrenia and consists of responses to 7 items (P2,N5,G5,G10,G11,G13,G15). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Disorganized Thought symptom score is the sum of the scores for all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.

    7. Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score. [Baseline and Day 42]

      PANSS Marder Factor Hostility/Excitement symptom score measures symptoms of schizophrenia and consists of responses to 4 items (P4,P7,G8,G14). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Hostility/Excitement symptom score is the sum of the scores for all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.

    8. Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score. [Baseline and Day 42]

      PANSS Marder Factor Anxiety/Depression symptom score measures symptoms of schizophrenia and consists of responses to 4 items (G2,G3,G4,G6). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Anxiety/Depression symptom score is the sum of the scores for all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.

    9. Percentage of Participants Who Were PANSS Responders. [Day 42]

      PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score is the sum of the scores for all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. The PANSS total score was determined at baseline and then at Day 42, and a participant with a 30% or greater reduction from baseline in PANSS total score at Day 42 was considered a PANSS responder.

    10. Change From Baseline in Clinical Global Impressions -Severity of Illness (CGI-S) Score. [Baseline and Day 42]

      The CGI-S is a score that measures the severity of overall bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. Change from baseline values that are negative represent an improvement in symptoms.

    11. Percentage of Participants Who Were Clinical Global Impressions - Improvement (CGI-I) Responders. [Day 42]

      The CGI-I is a score on a 7-point scale for assessing the change from preceding phase of overall symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-I score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. The CGI-I score was assessed at baseline and Day 42. Compared to the baseline measurement, a CGI-I responder had a score at Day 42 of 3 (minimally improved), 2 (much improved) or 1 (very much improved).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • current diagnosis of schizophrenia of paranoid, disorganized, catatonic, or undifferentiated (295.90) subtype

    • minimum Positive and Negative Syndrome Scale (PANSS) total score of 60 at screening and Baseline.

    • participant had a score of at least 4 in two or more of 5 items in the positive subscale of the PANSS at Screening and Baseline.

    • participant confirmed by the investigator to be experiencing an acute exacerbation of schizophrenia as evidenced by ALL of the following:

    • at the screening test, the duration of the current episode was no more than 2 months;

    • current symptoms represented a dramatic and substantial change compared to the participant's symptomatic state prior to the emergence of the current episode;

    • participant was in need of changing medication or dosage to treat newly appeared or worsened positive symptoms.

    • participant had a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at Baseline;

    • responded positively to an antipsychotic medication in a prior episode.

    • discontinued the use of all prohibited concomitant medications, with last dose taken no later than the evening prior to the baseline visit (For depot neuroleptic, discontinuation must have occurred more than 3 months prior to randomization).

    • participants must agree to inpatient status for screening period and for up to 42 days of dosing and, for out-patient phase, had a caregiver or an identified responsible person (e.g., family member, social worker, case worker, or nurse) whom the investigator accepts and who has agreed to provide support to the participant to ensure compliance with study treatment, out-patient visits, and protocol procedures.

    Exclusion Criteria:

    • not be treatment-refractory defined by the following criteria: (1) had been treated with at least two different atypical anti-psychotic agents at dosages equivalent to or greater than 600 mg/day of chlorpromazine (12 mg /day of haloperidol) for more than 4 weeks, each without clinical response, or (2) has received clozapine for 12 weeks immediately preceding the screening.

    • not have received treatment with 3 or more antipsychotic drugs, or dose-equivalents higher than 18 mg/day of haloperidol (equivalent 900 mg/day of chlorpromazine) within one month prior to randomization.

    • not have a diagnosis of schizoaffective disorder; schizophrenia of residual subtype; schizophreniform disorder, or schizophrenia with course specifiers continuous, single episode in partial remission, or single episode in full remission

    • not have a concurrent psychiatric disorder other than schizophrenia coded on Axis I; not have a primary diagnosis other than schizophrenia

    • not have had a known diagnosis of borderline personality disorder, mental retardation or organic brain disorder.

    • not have a 20% or greater decrease in PANSS total score from screening to baseline

    • not have an imminent risk of self-harm or harm to others, in the investigator's opinion.

    • not have a substance induced psychotic disorder or a behavioral disturbance thought to be due to substance abuse

    • not be currently under involuntary in-patient confinement.

    • not been previously treated with asenapine.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Organon and Co

    Investigators

    • Study Director: Medical Director, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT01098110
    Other Study ID Numbers:
    • P06124
    First Posted:
    Apr 2, 2010
    Last Update Posted:
    Feb 7, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Schizophrenia
    Asenapine

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Asenapine 5 mg BID Asenapine 10 mg BID Placebo BID
    Arm/Group Description Participants received a 5 mg asenapine fast dissolving tablet twice daily (BID) for 6 weeks. Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks. Participants received matching placebo BID for 6 weeks.
    Period Title: Overall Study
    STARTED 176 182 174
    Treated 175 181 174
    COMPLETED 114 109 80
    NOT COMPLETED 62 73 94

    Baseline Characteristics

    Arm/Group Title Asenapine 5 mg BID Asenapine 10 mg BID Placebo BID Total
    Arm/Group Description Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks. Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks. Participants received matching placebo BID for 6 weeks. Total of all reporting groups
    Overall Participants 175 181 174 530
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    41.41
    (11.00)
    41.72
    (11.10)
    41.11
    (12.27)
    41.42
    (11.45)
    Sex: Female, Male (Count of Participants)
    Female
    100
    57.1%
    82
    45.3%
    93
    53.4%
    275
    51.9%
    Male
    75
    42.9%
    99
    54.7%
    81
    46.6%
    255
    48.1%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score.
    Description PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score is the sum of the scores for all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. Change from baseline values that are negative represent an improvement in symptoms.
    Time Frame Baseline and Day 42

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the last observation carried forward (LOCF) method.
    Arm/Group Title Asenapine 5 mg BID Asenapine 10 mg BID Placebo BID
    Arm/Group Description Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks. Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks. Participants received matching placebo BID for 6 weeks.
    Measure Participants 173 178 174
    Least Squares Mean (95% Confidence Interval) [Score on a scale]
    -12.24
    -14.17
    -0.95
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Statistical significant: p=<0.05, two sided
    Method ANCOVA
    Comments Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.
    Method of Estimation Estimation Parameter Least square (LS) means difference
    Estimated Value -11.29
    Confidence Interval (2-Sided) 95%
    -15.42 to -7.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.10
    Estimation Comments Asenapine 5 mg BID minus Placebo BID
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Asenapine 10 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Statistical significant: p=<0.05, two sided
    Method ANCOVA
    Comments Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -13.22
    Confidence Interval (2-Sided) 95%
    -17.33 to -9.12
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.09
    Estimation Comments Asenapine 10 mg BID minus Placebo BID
    2. Secondary Outcome
    Title Change From Baseline in PANSS Positive Symptom Score.
    Description PANSS Positive subscale measures symptoms of schizophrenia and consists of responses to 7 items (P1-P7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Positive subscale sums all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.
    Time Frame Baseline and Day 42

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.
    Arm/Group Title Asenapine 5 mg BID Asenapine 10 mg BID Placebo BID
    Arm/Group Description Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks. Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks. Participants received matching placebo BID for 6 weeks.
    Measure Participants 173 178 174
    Least Squares Mean (95% Confidence Interval) [Score on a scale]
    -4.31
    -4.63
    -0.85
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments Change from baseline a response variable, baseline score a covariate.
    Method of Estimation Estimation Parameter Least square (LS) means difference
    Estimated Value -3.47
    Confidence Interval (2-Sided) 95%
    -4.80 to -2.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.68
    Estimation Comments Asenapine 5 mg BID minus Placebo BID
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Asenapine 10 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments Change from baseline a response variable, baseline score a covariate.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -3.79
    Confidence Interval (2-Sided) 95%
    -5.11 to -2.46
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.67
    Estimation Comments Asenapine 10 mg BID minus Placebo BID
    3. Secondary Outcome
    Title Change From Baseline in PANSS Negative Symptom Score.
    Description PANSS Negative subscale measures symptoms of schizophrenia and consists of responses to 7 items (N1-N7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Negative subscale sums all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. . An improvement in symptoms is represented by change from baseline values that are negative.
    Time Frame Baseline and Day 42

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. One participant from the 5 mg BID arm was missing a post-baseline measurement. Dropout or missing data are imputed by the LOCF method.
    Arm/Group Title Asenapine 5 mg BID Asenapine 10 mg BID Placebo BID
    Arm/Group Description Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks. Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks. Participants received matching placebo BID for 6 weeks.
    Measure Participants 172 178 174
    Least Squares Mean (95% Confidence Interval) [Score on a scale]
    -2.72
    -3.27
    -0.24
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.
    Method of Estimation Estimation Parameter Least square (LS) means difference
    Estimated Value -2.47
    Confidence Interval (2-Sided) 95%
    -3.53 to -1.41
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.54
    Estimation Comments Asenapine 5 mg BID minus Placebo BID
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Asenapine 10 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -3.03
    Confidence Interval (2-Sided) 95%
    -4.08 to -1.97
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.54
    Estimation Comments Asenapine 10 mg BID minus Placebo BID
    4. Secondary Outcome
    Title Change From Baseline in PANSS General Psychopathology Score.
    Description PANSS General Psychopathology subscale measures symptoms of schizophrenia and consists of responses to 16 items (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS General Psychopathology subscale is the sum of the scores for all 16 items and ranges from 16 to 112, with a higher score indicating greater severity of symptoms.. An improvement in symptoms is represented by change from baseline values that are negative.
    Time Frame Baseline and Day 42

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.
    Arm/Group Title Asenapine 5 mg BID Asenapine 10 mg BID Placebo BID
    Arm/Group Description Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks. Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks. Participants received matching placebo BID for 6 weeks.
    Measure Participants 173 178 174
    Least Squares Mean (95% Confidence Interval) [Score on a scale]
    -5.26
    -6.34
    0.19
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.
    Method of Estimation Estimation Parameter Least square (LS) means difference
    Estimated Value -5.46
    Confidence Interval (2-Sided) 95%
    -7.56 to -3.35
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.07
    Estimation Comments Asenapine 5 mg BID minus Placebo BID
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Asenapine 10 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Statistical significant: p=<0.05, two sided
    Method ANCOVA
    Comments Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -6.53
    Confidence Interval (2-Sided) 95%
    -8.62 to -4.44
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.06
    Estimation Comments Asenapine 10 mg BID minus Placebo BID
    5. Secondary Outcome
    Title Change From Baseline in PANSS Marder Factor Positive Symptom Score.
    Description PANSS Marder Factor Positive symptom score measures symptoms of schizophrenia and consists of responses to 8 items (P1,P3,P5,P6,N7,G1,G9,G12). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Positive symptom score is the sum of the scores for all 8 items and ranges from 8 to 56, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.
    Time Frame Baseline and Day 42

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.
    Arm/Group Title Asenapine 5 mg BID Asenapine 10 mg BID Placebo BID
    Arm/Group Description Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks. Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks. Participants received matching placebo BID for 6 weeks.
    Measure Participants 173 178 174
    Least Squares Mean (95% Confidence Interval) [Score on a scale]
    -4.78
    -5.03
    -1.37
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.
    Method of Estimation Estimation Parameter Least square (LS) means difference
    Estimated Value -3.41
    Confidence Interval (2-Sided) 95%
    -4.72 to -2.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.67
    Estimation Comments Asenapine 5 mg BID minus Placebo BID
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Asenapine 10 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -3.66
    Confidence Interval (2-Sided) 95%
    -4.97 to -2.35
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.67
    Estimation Comments Asenapine 10 mg BID minus Placebo BID
    6. Secondary Outcome
    Title Change From Baseline in PANSS Marder Factor Negative Symptom Score.
    Description PANSS Marder Factor Negative symptom score measures symptoms of schizophrenia and consists of responses to 7 items (N1,N2,N3,N4,N6,G7,G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Negative symptom score is the sum of the scores for all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.
    Time Frame Baseline and Day 42

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.
    Arm/Group Title Asenapine 5 mg BID Asenapine 10 mg BID Placebo BID
    Arm/Group Description Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks. Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks. Participants received matching placebo BID for 6 weeks.
    Measure Participants 173 178 174
    Least Squares Mean (95% Confidence Interval) [Score on a scale]
    -2.77
    -3.35
    -0.41
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments Change from baseline a response variable, baseline score a covariate.
    Method of Estimation Estimation Parameter Least square (LS) means difference
    Estimated Value -2.36
    Confidence Interval (2-Sided) 95%
    -3.47 to -1.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.56
    Estimation Comments Asenapine 5 mg BID minus Placebo BID
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Asenapine 10 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments Change from baseline a response variable, baseline score a covariate.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -2.94
    Confidence Interval (2-Sided) 95%
    -4.03 to -1.84
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.56
    Estimation Comments Asenapine 10 mg BID minus Placebo BID
    7. Secondary Outcome
    Title Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score.
    Description PANSS Marder Factor Disorganized Thought symptom score measures symptoms of schizophrenia and consists of responses to 7 items (P2,N5,G5,G10,G11,G13,G15). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Disorganized Thought symptom score is the sum of the scores for all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.
    Time Frame Baseline and Day 42

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. One participant from the 5 mg BID arm was missing a post-baseline measurement. Dropout or missing data are imputed by the LOCF method.
    Arm/Group Title Asenapine 5 mg BID Asenapine 10 mg BID Placebo BID
    Arm/Group Description Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks. Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks. Participants received matching placebo BID for 6 weeks.
    Measure Participants 172 178 174
    Least Squares Mean (95% Confidence Interval) [Score on a scale]
    -2.48
    -2.85
    0.24
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.
    Method of Estimation Estimation Parameter Least square (LS) means difference
    Estimated Value -2.72
    Confidence Interval (2-Sided) 95%
    -3.73 to -1.70
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.52
    Estimation Comments Asenapine 5 mg BID minus Placebo BID
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Asenapine 10 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -3.08
    Confidence Interval (2-Sided) 95%
    -4.09 to -2.08
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.51
    Estimation Comments Asenapine 10 mg BID minus Placebo BID
    8. Secondary Outcome
    Title Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score.
    Description PANSS Marder Factor Hostility/Excitement symptom score measures symptoms of schizophrenia and consists of responses to 4 items (P4,P7,G8,G14). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Hostility/Excitement symptom score is the sum of the scores for all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.
    Time Frame Baseline and Day 42

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method
    Arm/Group Title Asenapine 5 mg BID Asenapine 10 mg BID Placebo BID
    Arm/Group Description Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks. Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks. Participants received matching placebo BID for 6 weeks.
    Measure Participants 173 178 174
    Least Squares Mean (95% Confidence Interval) [Score on a scale]
    -0.77
    -1.40
    0.86
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.
    Method of Estimation Estimation Parameter Least square (LS) means difference
    Estimated Value -1.62
    Confidence Interval (2-Sided) 95%
    -2.41 to -0.83
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.40
    Estimation Comments Asenapine 5 mg BID minus Placebo BID
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Asenapine 10 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -2.26
    Confidence Interval (2-Sided) 95%
    -3.04 to -1.47
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.40
    Estimation Comments Asenapine 10 mg BID minus Placebo BID
    9. Secondary Outcome
    Title Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score.
    Description PANSS Marder Factor Anxiety/Depression symptom score measures symptoms of schizophrenia and consists of responses to 4 items (G2,G3,G4,G6). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Anxiety/Depression symptom score is the sum of the scores for all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.
    Time Frame Baseline and Day 42

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.
    Arm/Group Title Asenapine 5 mg BID Asenapine 10 mg BID Placebo BID
    Arm/Group Description Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks. Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks. Participants received matching placebo BID for 6 weeks.
    Measure Participants 173 178 174
    Least Squares Mean (95% Confidence Interval) [Score on a scale]
    -1.55
    -1.67
    -0.13
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.
    Method of Estimation Estimation Parameter Least square (LS) means difference
    Estimated Value -1.41
    Confidence Interval (2-Sided) 95%
    -2.04 to -0.78
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.32
    Estimation Comments Asenapine 5 mg BID minus Placebo BID
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Asenapine 10 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -1.53
    Confidence Interval (2-Sided) 95%
    -2.16 to -0.91
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.32
    Estimation Comments Asenapine 10 mg BID minus Placebo BID
    10. Secondary Outcome
    Title Percentage of Participants Who Were PANSS Responders.
    Description PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score is the sum of the scores for all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. The PANSS total score was determined at baseline and then at Day 42, and a participant with a 30% or greater reduction from baseline in PANSS total score at Day 42 was considered a PANSS responder.
    Time Frame Day 42

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.
    Arm/Group Title Asenapine 5 mg BID Asenapine 10 mg BID Placebo BID
    Arm/Group Description Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks. Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks. Participants received matching placebo BID for 6 weeks.
    Measure Participants 173 178 174
    Number (95% Confidence Interval) [Percentage of participants]
    39.3
    22.5%
    43.8
    24.2%
    20.7
    11.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments Adjusted for region.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 18.6
    Confidence Interval (2-Sided) 95%
    9.2 to 28.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments Asenapine 5 mg BID minus Placebo BID
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Asenapine 10 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Adjusted for region.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 23.1
    Confidence Interval (2-Sided) 95%
    13.7 to 32.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments Asenapine 10 mg BID minus Placebo BID
    11. Secondary Outcome
    Title Change From Baseline in Clinical Global Impressions -Severity of Illness (CGI-S) Score.
    Description The CGI-S is a score that measures the severity of overall bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. Change from baseline values that are negative represent an improvement in symptoms.
    Time Frame Baseline and Day 42

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.
    Arm/Group Title Asenapine 5 mg BID Asenapine 10 mg BID Placebo BID
    Arm/Group Description Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks. Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks. Participants received matching placebo BID for 6 weeks.
    Measure Participants 173 178 174
    Least Squares Mean (95% Confidence Interval) [Score on a scale]
    -0.69
    -0.77
    -0.18
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.
    Method of Estimation Estimation Parameter Least square (LS) means difference
    Estimated Value -0.52
    Confidence Interval (2-Sided) 95%
    -0.75 to -0.28
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments Asenapine 5 mg BID minus Placebo BID
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Asenapine 10 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method ANCOVA
    Comments Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.
    Method of Estimation Estimation Parameter LS mean difference
    Estimated Value -0.59
    Confidence Interval (2-Sided) 95%
    -0.82 to -0.36
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.12
    Estimation Comments Asenapine 10 mg BID minus Placebo BID
    12. Secondary Outcome
    Title Percentage of Participants Who Were Clinical Global Impressions - Improvement (CGI-I) Responders.
    Description The CGI-I is a score on a 7-point scale for assessing the change from preceding phase of overall symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-I score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. The CGI-I score was assessed at baseline and Day 42. Compared to the baseline measurement, a CGI-I responder had a score at Day 42 of 3 (minimally improved), 2 (much improved) or 1 (very much improved).
    Time Frame Day 42

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.
    Arm/Group Title Asenapine 5 mg BID Asenapine 10 mg BID Placebo BID
    Arm/Group Description Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks. Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks. Participants received matching placebo BID for 6 weeks.
    Measure Participants 173 178 174
    Number (95% Confidence Interval) [Percentage of participants]
    63.6
    36.3%
    70.2
    38.8%
    41.4
    23.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Asenapine 5 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Adjusted for region.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 22.2
    Confidence Interval (2-Sided) 95%
    12.0 to 32.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments Asenapine 5 mg BID minus Placebo BID
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Asenapine 10 mg BID, Placebo BID
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Adjusted for region.
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 28.8
    Confidence Interval (2-Sided) 95%
    18.9 to 38.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments Asenapine 10 mg BID minus Placebo BID

    Adverse Events

    Time Frame Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs
    Adverse Event Reporting Description Participants who received at least one dose of trial medication
    Arm/Group Title Asenapine 5 mg BID Asenapine 10 mg BID Placebo BID
    Arm/Group Description Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks. Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks. Participants received matching placebo BID for 6 weeks.
    All Cause Mortality
    Asenapine 5 mg BID Asenapine 10 mg BID Placebo BID
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Asenapine 5 mg BID Asenapine 10 mg BID Placebo BID
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 10/175 (5.7%) 5/181 (2.8%) 13/174 (7.5%)
    Cardiac disorders
    Sinus Bradycardia 0/175 (0%) 0 1/181 (0.6%) 1 0/174 (0%) 0
    Gastrointestinal disorders
    Vomiting 1/175 (0.6%) 1 0/181 (0%) 0 0/174 (0%) 0
    Metabolism and nutrition disorders
    Hyperkalaemia 0/175 (0%) 0 0/181 (0%) 0 1/174 (0.6%) 1
    Hypokalaemia 0/175 (0%) 0 0/181 (0%) 0 1/174 (0.6%) 1
    Nervous system disorders
    Epilepsy 0/175 (0%) 0 0/181 (0%) 0 1/174 (0.6%) 1
    Subarachnoid Hemorrhage 1/175 (0.6%) 1 0/181 (0%) 0 0/174 (0%) 0
    Psychiatric disorders
    Agitation 0/175 (0%) 0 0/181 (0%) 0 1/174 (0.6%) 1
    Schizophrenia 8/175 (4.6%) 8 4/181 (2.2%) 4 8/174 (4.6%) 8
    Schizophrenia, paranoid type 0/175 (0%) 0 0/181 (0%) 0 1/174 (0.6%) 1
    Suicide attempt 0/175 (0%) 0 0/181 (0%) 0 1/174 (0.6%) 1
    Skin and subcutaneous tissue disorders
    Rash 0/175 (0%) 0 1/181 (0.6%) 1 0/174 (0%) 0
    Other (Not Including Serious) Adverse Events
    Asenapine 5 mg BID Asenapine 10 mg BID Placebo BID
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 96/175 (54.9%) 110/181 (60.8%) 89/174 (51.1%)
    Gastrointestinal disorders
    Constipation 10/175 (5.7%) 10 13/181 (7.2%) 15 11/174 (6.3%) 12
    Hypoaesthesia oral 19/175 (10.9%) 20 17/181 (9.4%) 18 6/174 (3.4%) 6
    Infections and infestations
    Nasopharyngitis 13/175 (7.4%) 15 11/181 (6.1%) 13 8/174 (4.6%) 8
    Investigations
    Blood creatine phosphokinase increased 3/175 (1.7%) 4 12/181 (6.6%) 12 4/174 (2.3%) 4
    Nervous system disorders
    Akathisia 20/175 (11.4%) 22 19/181 (10.5%) 19 9/174 (5.2%) 9
    Dizziness 7/175 (4%) 8 17/181 (9.4%) 17 5/174 (2.9%) 5
    Extrapyramidal disorder 9/175 (5.1%) 9 14/181 (7.7%) 16 3/174 (1.7%) 3
    Headache 11/175 (6.3%) 12 10/181 (5.5%) 12 11/174 (6.3%) 12
    Somnolence 17/175 (9.7%) 17 22/181 (12.2%) 23 3/174 (1.7%) 3
    Psychiatric disorders
    Insomnia 17/175 (9.7%) 18 14/181 (7.7%) 16 21/174 (12.1%) 23
    Schizophrenia 15/175 (8.6%) 15 25/181 (13.8%) 25 42/174 (24.1%) 44

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    The investigator agrees to provide the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts, and to review and comment on the data analysis and presentation.

    Results Point of Contact

    Name/Title Senior Vice President, Global Clinical Development
    Organization Merck Sharp & Dohme Corp.
    Phone 1-800-672-6372
    Email ClinicalTrialsDisclosure@merck.com
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT01098110
    Other Study ID Numbers:
    • P06124
    First Posted:
    Apr 2, 2010
    Last Update Posted:
    Feb 7, 2022
    Last Verified:
    Feb 1, 2022