A Study of the Efficacy and Safety of Asenapine in Participants With an Acute Exacerbation of Schizophrenia (P05688)

A Multicenter, Randomized, Double-Blind, Fixed-Dose, 6-Week Trial of the Efficacy and Safety of Asenapine Compared With Placebo Using Olanzapine as an Active Control in Subjects With an Acute Exacerbation of Schizophrenia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01617187

Enrollment

360

Registered

2012-06-12

Start date

2012-12-04

Completion date

2014-09-09

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Brief summary

The purpose of this trial is to assess the effect of asenapine 2.5 and 5 mg sublingually twice daily (BID) compared with placebo in the treatment of schizophrenia (overall symptoms) as measured by the Positive and Negative Syndrome Scale (PANSS). Olanzapine administered 15 mg orally once daily (QD) was used as an active control. The primary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the change from Baseline in the PANSS total score at Day 42. The first key secondary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the change from Baseline in Clinical Global Impression Scale-Severity (CGI-S) score at Day 42. The second key secondary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the rate of PANSS responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42.

Detailed description

The trial consists of a screening/tapering period, treatment period, and follow-up period. The 6-week active treatment period includes an inpatient phase and outpatient phase. Participants who complete the trial may continue treatment under a long-term extension protocol (P05689). Participants who do not continue in the treatment continuation trial (whether they complete the 6-week trial or discontinue prematurely) will have a follow-up visit 7 days after their last dose of trial medication.

Interventions

DRUGAsenapine

2.5 mg or 5 mg fast dissolving active asenapine tablets administered sublingually

DRUGPlacebo Asenapine

Fast dissolving placebo asenapine tablets (to match 2.5 mg and 5 mg active asenapine tablets) administered sublingually

DRUGOlanzapine

5 and 10 mg film-coated active olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding

DRUGPlacebo Olanzapine

Film-coated placebo olanzapine tablets (to match 5 and 10 mg active olanzapine tablets) administered orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Current diagnosis of schizophrenia of paranoid, disorganized, or undifferentiated subtype * Minimum PANSS total score of 70 at Screening and Baseline * Score of at least 4 (moderate) in two or more of the five items in the positive subscale of the PANSS * Confirmed to be experiencing an acute exacerbation of schizophrenia * CGI-S scale score of at least 4 (moderately ill) at Baseline * Has responded positively to an antipsychotic medication other than clozapine (Clozaril®) in a prior episode

Exclusion criteria

* Body mass index (BMI) \<18.5 or \>40.0 kg/m\^2 * Laboratory and/or clinical evidence of clinically significant hepatic conditions * Known history of, or undergoing treatment for, narrow angle glaucoma * Diagnosed with epilepsy or has had any seizure disorder beyond childhood febrile seizures * Known serological evidence of human immunodeficiency virus (HIV) antibody * History of neuroleptic malignant syndrome or tardive dyskinesias * Past or current diagnosis of schizoaffective disorder, schizophrenia of residual subtype, schizophrenia of catatonic subtype, current diagnosis of schizophrenia with course specifiers continuous, single episode in partial remission, or single episode in full remission, or borderline personality disorder

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in PANSS Total Score at Day 42	Baseline and Day 42	The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 42; improvement in symptoms is represented by negative values.

Secondary

Measure	Time frame	Description
Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42	Baseline and Day 42	Rate of PANSS responders at Day 42 is a Key Secondary Outcome Measure. A PANSS responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS total score at a post-baseline assessment. The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. Missing data were imputed by Last Observation Carried Forward (LOCF).
Change From Baseline in Body Weight at Day 42	Baseline and Day 42	Change from baseline in body weight at Day 42 is the Key Safety Outcome Measure.
Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Baseline and Days 4, 7, 14, 21, 28 and 35	The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline; improvement in symptoms is represented by negative values.
Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Days 4, 7, 14, 21, 28 and 35	A PANSS responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS total score at a post-baseline assessment. The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF.
Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Baseline and Days 4, 7, 14, 21, 28 and 35	CGI-S is a 7-point scale for assessing the global severity of the participant's illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline; improvement in symptoms is represented by negative values.
Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Days 4, 7, 14, 21, 28, 35 and 42	A CGI-I responder was defined as a participant who had a CGI-I score of 1 (very much improved) or 2 (much improved) at a post-baseline assessment. CGI-I is a 7-point scale for assessing the global improvement of the participant's illness relative to baseline, with ratings from 1=very much improved to 7=very much worse. Missing data were imputed by LOCF.
Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Baseline and Days 4, 7, 14, 21, 28, 35 and 42	This measure reports results for the 7 items of the negative subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS negative subscale score for each participant was sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.
Change From Baseline in CGI-S Score at Day 42	Baseline and Day 42	Change from baseline in CGI-S score at Day 42 is a Key Secondary Outcome Measure. CGI-S is a 7-point scale for assessing the global severity of the participant's illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 42; improvement in symptoms is represented by negative values.
Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Baseline and Days 4, 7, 14, 21, 28, 35 and 42	This measure reports results for the 16 items of the general psychopathology subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS general psychopathology subscale score for each participant was calculated as the sum of the rating assigned to each of the 16 subscale items, and ranged from 16 to 112 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline; improvement in symptoms is represented by negative values.
Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Baseline and Days 4, 7, 14, 21, 28, 35 and 42	This measure reports results for the 8 items of the Marder positive symptom factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor positive symptom score for each participant was sum of rating assigned to each of the 8 applicable Marder factor items, and ranged from 8 to 56 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.
Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Baseline and Days 4, 7, 14, 21, 28, 35 and 42	This measure reports results for the 7 items of the Marder negative symptoms factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor negative symptom score for each participant was sum of the rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.
Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Baseline and Days 4, 7, 14, 21, 28, 35 and 42	This measure reports results for the 7 items of the Marder disorganized thoughts factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor disorganized thought symptom score for each participant was sum of rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.
Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Baseline and Days 4, 7, 14, 21, 28, 35 and 42	This measure reports results for the 4 items of the Marder hostility/excitement factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor hostility/excitement symptom score for each participant was sum of rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.
Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Baseline and Days 4, 7, 14, 21, 28, 35 and 42	This measure reports results for the 4 items of the Marder anxiety/depression factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor anxiety/depression symptom score for each participant was sum of rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.
Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Baseline and Days 4, 7, 14, 21, 28, 35 and 42	This measure reports results for the 7 items of the positive subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS positive subscale score for each participant was sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.

Participant flow

Pre-assignment details

One participant randomized to asenapine 2.5 mg BID did not receive study drug but was recorded in clinical database as completing the study. In Participant Flow table, this participant is presented as Not Completed in period Randomization through Start Treatment (Not Treated).

Participants by arm

Arm	Count
Asenapine 2.5 mg BID Participants were administered one 2.5 mg asenapine tablet BID for 42 days	97
Asenapine 5 mg BID Participants were administered one 5 mg asenapine tablet BID for 42 days	113
Olanzapine 15 mg QD Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered	46
Placebo BID Participants were administered placebo tablets BID for 42 days	101
Total	357

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Randomization Through Start Treatment	Not Treated: Administrative Reason	0	0	0	1
Randomization Through Start Treatment	Not Treated: Adverse Event	0	0	0	1
Randomization Through Start Treatment	Not Treated: Completed study in database	1	0	0	0
Treatment Through Study Completion	Adverse Event	1	1	0	1
Treatment Through Study Completion	Lost to Follow-up	4	2	2	2
Treatment Through Study Completion	Protocol Violation	1	0	0	1
Treatment Through Study Completion	Withdrawal by Subject	5	8	3	6

Baseline characteristics

Characteristic	Asenapine 2.5 mg BID	Asenapine 5 mg BID	Olanzapine 15 mg QD	Placebo BID	Total
Age, Continuous	41.5 years STANDARD_DEVIATION 10.79	39.1 years STANDARD_DEVIATION 10.68	40.8 years STANDARD_DEVIATION 11.15	41.4 years STANDARD_DEVIATION 12.05	40.6 years STANDARD_DEVIATION 11.18
Body Weight	81.6 kg STANDARD_DEVIATION 17.73	78.6 kg STANDARD_DEVIATION 17.88	80.7 kg STANDARD_DEVIATION 17.79	77.1 kg STANDARD_DEVIATION 17.56	79.3 kg STANDARD_DEVIATION 17.75
Clinical Global Impression Scale-Severity (CGI-S) score	4.8 score on a scale STANDARD_DEVIATION 0.64	4.9 score on a scale STANDARD_DEVIATION 0.64	4.8 score on a scale STANDARD_DEVIATION 0.61	4.8 score on a scale STANDARD_DEVIATION 0.61	4.8 score on a scale STANDARD_DEVIATION 0.63
PANSS general psychopathology subscale score	45.5 score on a scale STANDARD_DEVIATION 6.05	46.3 score on a scale STANDARD_DEVIATION 6.87	44.7 score on a scale STANDARD_DEVIATION 6.2	44.9 score on a scale STANDARD_DEVIATION 6.05	45.5 score on a scale STANDARD_DEVIATION 6.34
PANSS Marder factor anxiety/depression symptom score	11.0 score on a scale STANDARD_DEVIATION 2.97	10.9 score on a scale STANDARD_DEVIATION 3.13	10.9 score on a scale STANDARD_DEVIATION 3.62	10.7 score on a scale STANDARD_DEVIATION 2.96	10.9 score on a scale STANDARD_DEVIATION 3.09
PANSS Marder factor disorganized thought symptom score	21.5 score on a scale STANDARD_DEVIATION 4.32	22.6 score on a scale STANDARD_DEVIATION 4.93	21.2 score on a scale STANDARD_DEVIATION 4.29	21.6 score on a scale STANDARD_DEVIATION 4.42	21.8 score on a scale STANDARD_DEVIATION 4.56
PANSS Marder factor hostility/excitement symptom score	9.0 score on a scale STANDARD_DEVIATION 2.99	9.4 score on a scale STANDARD_DEVIATION 3.49	8.7 score on a scale STANDARD_DEVIATION 3.11	8.8 score on a scale STANDARD_DEVIATION 3.22	9.0 score on a scale STANDARD_DEVIATION 3.23
PANSS Marder factor negative symptom score	22.6 score on a scale STANDARD_DEVIATION 4.3	23.0 score on a scale STANDARD_DEVIATION 4.66	23.0 score on a scale STANDARD_DEVIATION 4.44	22.8 score on a scale STANDARD_DEVIATION 4.76	22.8 score on a scale STANDARD_DEVIATION 4.55
PANSS Marder factor positive symptom score	29.3 score on a scale STANDARD_DEVIATION 5.02	30.0 score on a scale STANDARD_DEVIATION 5.05	29.0 score on a scale STANDARD_DEVIATION 4.69	29.4 score on a scale STANDARD_DEVIATION 4.36	29.5 score on a scale STANDARD_DEVIATION 4.8
PANSS negative subscale score	23.5 score on a scale STANDARD_DEVIATION 4.47	24.1 score on a scale STANDARD_DEVIATION 4.5	23.4 score on a scale STANDARD_DEVIATION 3.96	23.9 score on a scale STANDARD_DEVIATION 4.22	23.8 score on a scale STANDARD_DEVIATION 4.34
PANSS positive subscale score	24.4 score on a scale STANDARD_DEVIATION 4.05	25.5 score on a scale STANDARD_DEVIATION 4.76	24.6 score on a scale STANDARD_DEVIATION 3.46	24.6 score on a scale STANDARD_DEVIATION 3.88	24.8 score on a scale STANDARD_DEVIATION 4.19
Positive and Negative Syndrome Scale (PANSS) total score	93.3 score on a scale STANDARD_DEVIATION 11.1	95.8 score on a scale STANDARD_DEVIATION 13.77	92.7 score on a scale STANDARD_DEVIATION 10.47	93.4 score on a scale STANDARD_DEVIATION 11.16	94.1 score on a scale STANDARD_DEVIATION 11.97
Sex: Female, Male Female	39 Participants	44 Participants	18 Participants	47 Participants	148 Participants
Sex: Female, Male Male	58 Participants	69 Participants	28 Participants	54 Participants	209 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	27 / 97	47 / 113	17 / 46	29 / 101
serious Total, serious adverse events	5 / 97	5 / 113	1 / 46	8 / 101

Outcome results

Primary

Change From Baseline in PANSS Total Score at Day 42

The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 42; improvement in symptoms is represented by negative values.

Time frame: Baseline and Day 42

Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Asenapine 2.5 mg BID	Change From Baseline in PANSS Total Score at Day 42	-17.4 score on a scale	Standard Error 1.8
Asenapine 5 mg BID	Change From Baseline in PANSS Total Score at Day 42	-21.7 score on a scale	Standard Error 1.6
Olanzapine 15 mg QD	Change From Baseline in PANSS Total Score at Day 42	-21.6 score on a scale	Standard Error 2.32
Placebo BID	Change From Baseline in PANSS Total Score at Day 42	-16.2 score on a scale	Standard Error 1.71

p-value: 0.604395% CI: [-6.1, 3.6]Mixed Model Repeated Measures (MMRM)

p-value: 0.035695% CI: [-10.1, -1]MMRM

p-value: 0.058795% CI: [-11.1, 0.2]MMRM

Secondary

Change From Baseline in Body Weight at Day 42

Change from baseline in body weight at Day 42 is the Key Safety Outcome Measure.

Time frame: Baseline and Day 42

Population: All randomized participants who received ≥1 dose of study drug

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Asenapine 2.5 mg BID	Change From Baseline in Body Weight at Day 42	1.3 kg	Standard Error 0.38
Asenapine 5 mg BID	Change From Baseline in Body Weight at Day 42	1.3 kg	Standard Error 0.33
Olanzapine 15 mg QD	Change From Baseline in Body Weight at Day 42	2.4 kg	Standard Error 0.47
Placebo BID	Change From Baseline in Body Weight at Day 42	0.3 kg	Standard Error 0.35

p-value: 0.049195% CI: [-2.4, 0]MMRM

p-value: 0.049195% CI: [-2.3, 0]MMRM

p-value: 0.056795% CI: [0, 2]MMRM

p-value: 0.039195% CI: [0, 1.9]MMRM

p-value: 0.000395% CI: [1, 3.3]MMRM

Secondary

Change From Baseline in CGI-S Score at Day 42

Change from baseline in CGI-S score at Day 42 is a Key Secondary Outcome Measure. CGI-S is a 7-point scale for assessing the global severity of the participant's illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 42; improvement in symptoms is represented by negative values.

Time frame: Baseline and Day 42

Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Asenapine 2.5 mg BID	Change From Baseline in CGI-S Score at Day 42	-0.9 score on a scale	Standard Error 0.11
Asenapine 5 mg BID	Change From Baseline in CGI-S Score at Day 42	-1.2 score on a scale	Standard Error 0.1
Olanzapine 15 mg QD	Change From Baseline in CGI-S Score at Day 42	-1.1 score on a scale	Standard Error 0.14
Placebo BID	Change From Baseline in CGI-S Score at Day 42	-1.0 score on a scale	Standard Error 0.11

Comparison: Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)p-value: 0.908395% CI: [-0.3, 0.3]MMRM

p-value: 0.389895% CI: [-0.5, 0.2]MMRM

Secondary

Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35

CGI-S is a 7-point scale for assessing the global severity of the participant's illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline; improvement in symptoms is represented by negative values.

Time frame: Baseline and Days 4, 7, 14, 21, 28 and 35

Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Asenapine 2.5 mg BID	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 7	-0.3 score on a scale	Standard Error 0.07
Asenapine 2.5 mg BID	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 21	-0.6 score on a scale	Standard Error 0.1
Asenapine 2.5 mg BID	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 35	-0.9 score on a scale	Standard Error 0.11
Asenapine 2.5 mg BID	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 28	-0.7 score on a scale	Standard Error 0.11
Asenapine 2.5 mg BID	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 4	-0.1 score on a scale	Standard Error 0.05
Asenapine 2.5 mg BID	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 14	-0.6 score on a scale	Standard Error 0.08
Asenapine 5 mg BID	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 4	-0.2 score on a scale	Standard Error 0.05
Asenapine 5 mg BID	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 7	-0.3 score on a scale	Standard Error 0.06
Asenapine 5 mg BID	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 28	-0.9 score on a scale	Standard Error 0.09
Asenapine 5 mg BID	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 35	-1.1 score on a scale	Standard Error 0.1
Asenapine 5 mg BID	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 21	-0.8 score on a scale	Standard Error 0.09
Asenapine 5 mg BID	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 14	-0.6 score on a scale	Standard Error 0.07
Olanzapine 15 mg QD	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 4	-0.2 score on a scale	Standard Error 0.07
Olanzapine 15 mg QD	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 21	-0.8 score on a scale	Standard Error 0.13
Olanzapine 15 mg QD	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 35	-1.0 score on a scale	Standard Error 0.14
Olanzapine 15 mg QD	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 7	-0.3 score on a scale	Standard Error 0.1
Olanzapine 15 mg QD	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 14	-0.6 score on a scale	Standard Error 0.11
Olanzapine 15 mg QD	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 28	-0.8 score on a scale	Standard Error 0.14
Placebo BID	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 14	-0.5 score on a scale	Standard Error 0.08
Placebo BID	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 35	-0.8 score on a scale	Standard Error 0.1
Placebo BID	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 28	-0.8 score on a scale	Standard Error 0.1
Placebo BID	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 4	-0.2 score on a scale	Standard Error 0.05
Placebo BID	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 21	-0.7 score on a scale	Standard Error 0.09
Placebo BID	Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35	Day 7	-0.3 score on a scale	Standard Error 0.07

Comparison: Day 7p-value: 0.875995% CI: [-0.2, 0.2]MMRM

Comparison: Day 7p-value: 0.959895% CI: [-0.2, 0.2]MMRM

Comparison: Day 4p-value: 0.425595% CI: [-0.1, 0.2]MMRM

Comparison: Day 4p-value: 0.956495% CI: [-0.1, 0.1]MMRM

Comparison: Day 4p-value: 0.636395% CI: [-0.2, 0.1]MMRM

Comparison: Day 7p-value: 0.978995% CI: [-0.2, 0.2]MMRM

Comparison: Day 14p-value: 0.467195% CI: [-0.3, 0.1]MMRM

Comparison: Day 14p-value: 0.635995% CI: [-0.3, 0.2]MMRM

Comparison: Day 14p-value: 0.545495% CI: [-0.4, 0.2]MMRM

Comparison: Day 21p-value: 0.418895% CI: [-0.2, 0.4]MMRM

Comparison: Day 21p-value: 0.531895% CI: [-0.3, 0.2]MMRM

Comparison: Day 21p-value: 0.568395% CI: [-0.4, 0.2]MMRM

Comparison: Day 28p-value: 0.297295% CI: [-0.1, 0.4]MMRM

Comparison: Day 28p-value: 0.48295% CI: [-0.4, 0.2]MMRM

Comparison: Day 28p-value: 0.990195% CI: [-0.3, 0.3]MMRM

Comparison: Day 35p-value: 0.668295% CI: [-0.4, 0.2]MMRM

Comparison: Day 35p-value: 0.111195% CI: [-0.5, 0.1]MMRM

Comparison: Day 35p-value: 0.2495% CI: [-0.5, 0.1]MMRM

Secondary

Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42

This measure reports results for the 16 items of the general psychopathology subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS general psychopathology subscale score for each participant was calculated as the sum of the rating assigned to each of the 16 subscale items, and ranged from 16 to 112 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline; improvement in symptoms is represented by negative values.

Time frame: Baseline and Days 4, 7, 14, 21, 28, 35 and 42

Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Asenapine 2.5 mg BID	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-5.9 score on a scale	Standard Error 0.93
Asenapine 2.5 mg BID	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-8.8 score on a scale	Standard Error 0.88
Asenapine 2.5 mg BID	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-8.9 score on a scale	Standard Error 0.97
Asenapine 2.5 mg BID	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-3.8 score on a scale	Standard Error 0.69
Asenapine 2.5 mg BID	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-5.9 score on a scale	Standard Error 0.84
Asenapine 2.5 mg BID	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-2.2 score on a scale	Standard Error 0.49
Asenapine 2.5 mg BID	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-5.1 score on a scale	Standard Error 0.73
Asenapine 5 mg BID	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-9.2 score on a scale	Standard Error 0.79
Asenapine 5 mg BID	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-8.2 score on a scale	Standard Error 0.82
Asenapine 5 mg BID	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-10.1 score on a scale	Standard Error 0.86
Asenapine 5 mg BID	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-2.7 score on a scale	Standard Error 0.46
Asenapine 5 mg BID	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-7.4 score on a scale	Standard Error 0.76
Asenapine 5 mg BID	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-4.9 score on a scale	Standard Error 0.64
Asenapine 5 mg BID	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-6.2 score on a scale	Standard Error 0.66
Olanzapine 15 mg QD	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-10.4 score on a scale	Standard Error 1.23
Olanzapine 15 mg QD	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-7.7 score on a scale	Standard Error 1.13
Olanzapine 15 mg QD	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-2.5 score on a scale	Standard Error 0.7
Olanzapine 15 mg QD	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-4.4 score on a scale	Standard Error 0.98
Olanzapine 15 mg QD	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-6.4 score on a scale	Standard Error 1
Olanzapine 15 mg QD	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-8.6 score on a scale	Standard Error 1.21
Olanzapine 15 mg QD	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-10.2 score on a scale	Standard Error 1.16
Placebo BID	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-5.4 score on a scale	Standard Error 0.71
Placebo BID	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-3.6 score on a scale	Standard Error 0.68
Placebo BID	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-6.7 score on a scale	Standard Error 0.81
Placebo BID	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-7.6 score on a scale	Standard Error 0.84
Placebo BID	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-2.4 score on a scale	Standard Error 0.49
Placebo BID	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-8.0 score on a scale	Standard Error 0.92
Placebo BID	Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-7.7 score on a scale	Standard Error 0.88

Comparison: Day 4p-value: 0.781995% CI: [-1.1, 1.5]MMRM

Comparison: Day 4p-value: 0.70395% CI: [-1.5, 1]MMRM

Comparison: Day 4p-value: 0.95295% CI: [-1.7, 1.6]MMRM

Comparison: Day 7p-value: 0.790795% CI: [-2.1, 1.6]MMRM

Comparison: Day 7p-value: 0.139195% CI: [-3.1, 0.4]MMRM

Comparison: Day 7p-value: 0.490195% CI: [-3.1, 1.5]MMRM

Comparison: Day 14p-value: 0.807995% CI: [-1.7, 2.2]MMRM

Comparison: Day 14p-value: 0.388995% CI: [-2.7, 1.1]MMRM

Comparison: Day 14p-value: 0.390795% CI: [-3.4, 1.3]MMRM

Comparison: Day 21p-value: 0.536395% CI: [-1.5, 3]MMRM

Comparison: Day 21p-value: 0.507595% CI: [-2.9, 1.4]MMRM

Comparison: Day 21p-value: 0.452695% CI: [-3.7, 1.7]MMRM

Comparison: Day 28p-value: 0.154895% CI: [-0.7, 4.3]MMRM

Comparison: Day 28p-value: 0.658995% CI: [-2.9, 1.8]MMRM

Comparison: Day 28p-value: 0.517195% CI: [-3.9, 2]MMRM

Comparison: Day 35p-value: 0.313395% CI: [-3.6, 1.2]MMRM

Comparison: Day 35p-value: 0.172395% CI: [-3.8, 0.7]MMRM

Comparison: Day 35p-value: 0.066395% CI: [-5.4, 0.2]MMRM

Comparison: Day 42p-value: 0.512895% CI: [-3.5, 1.7]MMRM

Comparison: Day 42p-value: 0.084295% CI: [-4.6, 0.3]MMRM

Comparison: Day 42p-value: 0.121795% CI: [-5.4, 0.6]MMRM

Secondary

Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42

This measure reports results for the 4 items of the Marder anxiety/depression factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor anxiety/depression symptom score for each participant was sum of rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.

Time frame: Baseline and Days 4, 7, 14, 21, 28, 35 and 42

Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-2.1 score on a scale	Standard Error 0.32
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-1.9 score on a scale	Standard Error 0.31
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-0.9 score on a scale	Standard Error 0.27
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-3.0 score on a scale	Standard Error 0.34
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-1.9 score on a scale	Standard Error 0.36
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-2.9 score on a scale	Standard Error 0.4
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-1.5 score on a scale	Standard Error 0.3
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-2.2 score on a scale	Standard Error 0.28
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-2.9 score on a scale	Standard Error 0.28
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-3.6 score on a scale	Standard Error 0.3
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-3.0 score on a scale	Standard Error 0.29
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-3.2 score on a scale	Standard Error 0.32
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-3.4 score on a scale	Standard Error 0.35
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-1.2 score on a scale	Standard Error 0.25
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-3.1 score on a scale	Standard Error 0.5
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-1.8 score on a scale	Standard Error 0.43
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-3.2 score on a scale	Standard Error 0.44
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-1.0 score on a scale	Standard Error 0.38
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-2.5 score on a scale	Standard Error 0.42
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-2.7 score on a scale	Standard Error 0.42
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-2.8 score on a scale	Standard Error 0.47
Placebo BID	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-3.1 score on a scale	Standard Error 0.31
Placebo BID	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-1.7 score on a scale	Standard Error 0.3
Placebo BID	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-3.2 score on a scale	Standard Error 0.32
Placebo BID	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-3.4 score on a scale	Standard Error 0.35
Placebo BID	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-0.9 score on a scale	Standard Error 0.27
Placebo BID	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-2.5 score on a scale	Standard Error 0.3
Placebo BID	Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-3.0 score on a scale	Standard Error 0.38

Comparison: Day 4p-value: 0.985195% CI: [-0.7, 0.7]MMRM

Comparison: Day 4p-value: 0.491295% CI: [-0.9, 0.5]MMRM

Comparison: Day 4p-value: 0.855995% CI: [-1, 0.8]MMRM

Comparison: Day 7p-value: 0.563595% CI: [-0.6, 1.1]MMRM

Comparison: Day 7p-value: 0.232195% CI: [-1.3, 0.3]MMRM

Comparison: Day 7p-value: 0.886795% CI: [-1.1, 0.9]MMRM

Comparison: Day 14p-value: 0.149995% CI: [-0.2, 1.4]MMRM

Comparison: Day 14p-value: 0.28695% CI: [-1.2, 0.4]MMRM

Comparison: Day 14p-value: 0.897895% CI: [-1.1, 0.9]MMRM

Comparison: Day 21p-value: 0.028395% CI: [0.1, 1.8]MMRM

Comparison: Day 21p-value: 0.866795% CI: [-0.7, 0.9]MMRM

Comparison: Day 21p-value: 0.504495% CI: [-0.7, 1.4]MMRM

Comparison: Day 28p-value: 0.00495% CI: [0.5, 2.4]MMRM

Comparison: Day 28p-value: 0.63395% CI: [-0.7, 1.1]MMRM

Comparison: Day 28p-value: 0.298195% CI: [-0.5, 1.7]MMRM

Comparison: Day 35p-value: 0.655695% CI: [-0.7, 1.1]MMRM

Comparison: Day 35p-value: 0.288995% CI: [-1.3, 0.4]MMRM

Comparison: Day 35p-value: 0.939995% CI: [-1.1, 1]MMRM

Comparison: Day 42p-value: 0.895595% CI: [-1, 1.1]MMRM

Comparison: Day 42p-value: 0.368195% CI: [-1.5, 0.5]MMRM

Comparison: Day 42p-value: 0.821595% CI: [-1.4, 1.1]MMRM

Secondary

Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42

This measure reports results for the 7 items of the Marder disorganized thoughts factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor disorganized thought symptom score for each participant was sum of rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.

Time frame: Baseline and Days 4, 7, 14, 21, 28, 35 and 42

Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-2.3 score on a scale	Standard Error 0.41
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-3.8 score on a scale	Standard Error 0.45
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-1.0 score on a scale	Standard Error 0.32
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-2.4 score on a scale	Standard Error 0.42
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-3.5 score on a scale	Standard Error 0.43
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-1.3 score on a scale	Standard Error 0.36
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-0.3 score on a scale	Standard Error 0.24
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-2.0 score on a scale	Standard Error 0.33
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-3.1 score on a scale	Standard Error 0.37
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-2.5 score on a scale	Standard Error 0.37
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-4.3 score on a scale	Standard Error 0.4
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-0.7 score on a scale	Standard Error 0.22
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-1.4 score on a scale	Standard Error 0.29
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-3.5 score on a scale	Standard Error 0.38
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-4.7 score on a scale	Standard Error 0.58
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-1.1 score on a scale	Standard Error 0.34
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-1.6 score on a scale	Standard Error 0.45
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-2.2 score on a scale	Standard Error 0.49
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-2.7 score on a scale	Standard Error 0.54
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-3.1 score on a scale	Standard Error 0.54
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-4.3 score on a scale	Standard Error 0.56
Placebo BID	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-2.7 score on a scale	Standard Error 0.43
Placebo BID	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-0.7 score on a scale	Standard Error 0.31
Placebo BID	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-2.4 score on a scale	Standard Error 0.4
Placebo BID	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-2.4 score on a scale	Standard Error 0.41
Placebo BID	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-0.7 score on a scale	Standard Error 0.24
Placebo BID	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-2.1 score on a scale	Standard Error 0.39
Placebo BID	Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-1.5 score on a scale	Standard Error 0.35

Comparison: Day 4p-value: 0.211695% CI: [-0.2, 1]MMRM

Comparison: Day 4p-value: 0.903995% CI: [-0.6, 0.7]MMRM

Comparison: Day 4p-value: 0.295995% CI: [-1.2, 0.4]MMRM

Comparison: Day 7p-value: 0.590995% CI: [-1.1, 0.6]MMRM

Comparison: Day 7p-value: 0.148995% CI: [-1.4, 0.2]MMRM

Comparison: Day 7p-value: 0.195% CI: [-2, 0.2]MMRM

Comparison: Day 14p-value: 0.78395% CI: [-0.8, 1.1]MMRM

Comparison: Day 14p-value: 0.267995% CI: [-1.4, 0.4]MMRM

Comparison: Day 14p-value: 0.232195% CI: [-1.9, 0.5]MMRM

Comparison: Day 21p-value: 0.736895% CI: [-1.3, 0.9]MMRM

Comparison: Day 21p-value: 0.460695% CI: [-1.4, 0.7]MMRM

Comparison: Day 21p-value: 0.324195% CI: [-2, 0.7]MMRM

Comparison: Day 28p-value: 0.98695% CI: [-1.1, 1.1]MMRM

Comparison: Day 28p-value: 0.18995% CI: [-1.8, 0.3]MMRM

Comparison: Day 28p-value: 0.30395% CI: [-2, 0.6]MMRM

Comparison: Day 35p-value: 0.05595% CI: [-2.3, 0]MMRM

Comparison: Day 35p-value: 0.041595% CI: [-2.2, 0]MMRM

Comparison: Day 35p-value: 0.005895% CI: [-3.3, -0.6]MMRM

Comparison: Day 42p-value: 0.069195% CI: [-2.3, 0.1]MMRM

Comparison: Day 42p-value: 0.006395% CI: [-2.7, -0.5]MMRM

Comparison: Day 42p-value: 0.005695% CI: [-3.4, -0.6]MMRM

Secondary

Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42

This measure reports results for the 4 items of the Marder hostility/excitement factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor hostility/excitement symptom score for each participant was sum of rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.

Time frame: Baseline and Days 4, 7, 14, 21, 28, 35 and 42

Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-0.4 score on a scale	Standard Error 0.25
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-0.5 score on a scale	Standard Error 0.41
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-0.5 score on a scale	Standard Error 0.28
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-0.9 score on a scale	Standard Error 0.3
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-0.8 score on a scale	Standard Error 0.33
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-1.1 score on a scale	Standard Error 0.41
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-1.4 score on a scale	Standard Error 0.37
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-0.9 score on a scale	Standard Error 0.3
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-0.8 score on a scale	Standard Error 0.36
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-0.3 score on a scale	Standard Error 0.23
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-0.5 score on a scale	Standard Error 0.26
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-0.8 score on a scale	Standard Error 0.27
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-1.5 score on a scale	Standard Error 0.32
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-1.8 score on a scale	Standard Error 0.36
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-1.2 score on a scale	Standard Error 0.41
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-1.8 score on a scale	Standard Error 0.44
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-1.0 score on a scale	Standard Error 0.4
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-1.6 score on a scale	Standard Error 0.53
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-1.9 score on a scale	Standard Error 0.52
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-2.0 score on a scale	Standard Error 0.47
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-0.7 score on a scale	Standard Error 0.36
Placebo BID	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-1.1 score on a scale	Standard Error 0.39
Placebo BID	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-0.9 score on a scale	Standard Error 0.3
Placebo BID	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-1.0 score on a scale	Standard Error 0.32
Placebo BID	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-1.4 score on a scale	Standard Error 0.35
Placebo BID	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-0.7 score on a scale	Standard Error 0.28
Placebo BID	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-1.0 score on a scale	Standard Error 0.39
Placebo BID	Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-0.5 score on a scale	Standard Error 0.25

Comparison: Day 4p-value: 0.784795% CI: [-0.6, 0.8]MMRM

Comparison: Day 4p-value: 0.585995% CI: [-0.5, 0.8]MMRM

Comparison: Day 4p-value: 0.641395% CI: [-1, 0.6]MMRM

Comparison: Day 7p-value: 0.730795% CI: [-0.6, 0.9]MMRM

Comparison: Day 7p-value: 0.717695% CI: [-0.6, 0.9]MMRM

Comparison: Day 7p-value: 0.48695% CI: [-1.3, 0.6]MMRM

Comparison: Day 14p-value: 0.932195% CI: [-0.8, 0.8]MMRM

Comparison: Day 14p-value: 0.769195% CI: [-0.7, 0.9]MMRM

Comparison: Day 14p-value: 0.569495% CI: [-1.3, 0.7]MMRM

Comparison: Day 21p-value: 0.558395% CI: [-0.6, 1.2]MMRM

Comparison: Day 21p-value: 0.730795% CI: [-0.7, 1]MMRM

Comparison: Day 21p-value: 0.171595% CI: [-1.8, 0.3]MMRM

Comparison: Day 28p-value: 0.421995% CI: [-0.6, 1.5]MMRM

Comparison: Day 28p-value: 0.743795% CI: [-0.9, 1.2]MMRM

Comparison: Day 28p-value: 0.31195% CI: [-1.9, 0.6]MMRM

Comparison: Day 35p-value: 0.980595% CI: [-1, 1]MMRM

Comparison: Day 35p-value: 0.874195% CI: [-1, 0.8]MMRM

Comparison: Day 35p-value: 0.328895% CI: [-1.7, 0.6]MMRM

Comparison: Day 42p-value: 0.933695% CI: [-1, 1.1]MMRM

Comparison: Day 42p-value: 0.172295% CI: [-1.7, 0.3]MMRM

Comparison: Day 42p-value: 0.190995% CI: [-2.1, 0.4]MMRM

Secondary

Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42

This measure reports results for the 7 items of the Marder negative symptoms factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor negative symptom score for each participant was sum of the rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.

Time frame: Baseline and Days 4, 7, 14, 21, 28, 35 and 42

Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-2.6 score on a scale	Standard Error 0.44
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-2.9 score on a scale	Standard Error 0.51
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-3.5 score on a scale	Standard Error 0.52
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-1.2 score on a scale	Standard Error 0.3
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-1.7 score on a scale	Standard Error 0.37
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-3.4 score on a scale	Standard Error 0.53
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-2.0 score on a scale	Standard Error 0.41
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-2.8 score on a scale	Standard Error 0.37
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-3.2 score on a scale	Standard Error 0.4
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-3.9 score on a scale	Standard Error 0.46
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-3.8 score on a scale	Standard Error 0.45
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-4.7 score on a scale	Standard Error 0.47
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-0.8 score on a scale	Standard Error 0.28
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-1.9 score on a scale	Standard Error 0.34
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-4.1 score on a scale	Standard Error 0.68
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-4.3 score on a scale	Standard Error 0.67
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-0.8 score on a scale	Standard Error 0.43
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-1.8 score on a scale	Standard Error 0.53
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-2.2 score on a scale	Standard Error 0.56
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-2.6 score on a scale	Standard Error 0.6
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-3.2 score on a scale	Standard Error 0.67
Placebo BID	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-4.0 score on a scale	Standard Error 0.51
Placebo BID	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-1.3 score on a scale	Standard Error 0.37
Placebo BID	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-2.0 score on a scale	Standard Error 0.4
Placebo BID	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-2.5 score on a scale	Standard Error 0.43
Placebo BID	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-3.5 score on a scale	Standard Error 0.49
Placebo BID	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-3.0 score on a scale	Standard Error 0.49
Placebo BID	Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-0.7 score on a scale	Standard Error 0.3

Comparison: Day 4p-value: 0.275495% CI: [-1.2, 0.4]MMRM

Comparison: Day 4p-value: 0.8595% CI: [-0.8, 0.7]MMRM

Comparison: Day 4p-value: 0.843995% CI: [-1.1, 0.9]MMRM

Comparison: Day 7p-value: 0.474195% CI: [-1.4, 0.6]MMRM

Comparison: Day 7p-value: 0.215895% CI: [-1.6, 0.4]MMRM

Comparison: Day 7p-value: 0.50695% CI: [-1.7, 0.8]MMRM

Comparison: Day 14p-value: 0.995695% CI: [-1.1, 1.1]MMRM

Comparison: Day 14p-value: 0.162495% CI: [-1.8, 0.3]MMRM

Comparison: Day 14p-value: 0.766295% CI: [-1.5, 1.1]MMRM

Comparison: Day 21p-value: 0.836395% CI: [-1.3, 1.1]MMRM

Comparison: Day 21p-value: 0.238895% CI: [-1.8, 0.5]MMRM

Comparison: Day 21p-value: 0.943595% CI: [-1.5, 1.4]MMRM

Comparison: Day 28p-value: 0.426795% CI: [-0.8, 1.9]MMRM

Comparison: Day 28p-value: 0.68195% CI: [-1.6, 1]MMRM

Comparison: Day 28p-value: 0.767395% CI: [-1.4, 1.9]MMRM

Comparison: Day 35p-value: 0.48395% CI: [-1.9, 0.9]MMRM

Comparison: Day 35p-value: 0.212895% CI: [-2.1, 0.5]MMRM

Comparison: Day 35p-value: 0.175695% CI: [-2.8, 0.5]MMRM

Comparison: Day 42p-value: 0.424695% CI: [-0.8, 2]MMRM

Comparison: Day 42p-value: 0.287395% CI: [-2.1, 0.6]MMRM

Comparison: Day 42p-value: 0.730895% CI: [-1.9, 1.4]MMRM

Secondary

Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42

This measure reports results for the 8 items of the Marder positive symptom factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor positive symptom score for each participant was sum of rating assigned to each of the 8 applicable Marder factor items, and ranged from 8 to 56 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.

Time frame: Baseline and Days 4, 7, 14, 21, 28, 35 and 42

Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-1.3 score on a scale	Standard Error 0.29
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-3.9 score on a scale	Standard Error 0.49
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-6.8 score on a scale	Standard Error 0.67
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-4.5 score on a scale	Standard Error 0.55
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-4.8 score on a scale	Standard Error 0.6
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-6.1 score on a scale	Standard Error 0.64
Asenapine 2.5 mg BID	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-2.5 score on a scale	Standard Error 0.41
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-7.6 score on a scale	Standard Error 0.59
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-1.8 score on a scale	Standard Error 0.27
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-2.9 score on a scale	Standard Error 0.38
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-4.0 score on a scale	Standard Error 0.44
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-5.4 score on a scale	Standard Error 0.5
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-6.3 score on a scale	Standard Error 0.53
Asenapine 5 mg BID	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-6.7 score on a scale	Standard Error 0.57
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-6.9 score on a scale	Standard Error 0.84
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-4.4 score on a scale	Standard Error 0.67
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-5.5 score on a scale	Standard Error 0.74
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-6.6 score on a scale	Standard Error 0.78
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-7.8 score on a scale	Standard Error 0.86
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-2.0 score on a scale	Standard Error 0.41
Olanzapine 15 mg QD	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-3.2 score on a scale	Standard Error 0.58
Placebo BID	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-5.6 score on a scale	Standard Error 0.57
Placebo BID	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-6.2 score on a scale	Standard Error 0.63
Placebo BID	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-6.1 score on a scale	Standard Error 0.61
Placebo BID	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-2.8 score on a scale	Standard Error 0.4
Placebo BID	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-5.1 score on a scale	Standard Error 0.54
Placebo BID	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-4.1 score on a scale	Standard Error 0.47
Placebo BID	Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-2.0 score on a scale	Standard Error 0.29

Comparison: Day 4p-value: 0.058495% CI: [0, 1.5]MMRM

Comparison: Day 4p-value: 0.519795% CI: [-0.5, 1]MMRM

Comparison: Day 4p-value: 0.969395% CI: [-0.9, 1]MMRM

Comparison: Day 7p-value: 0.616195% CI: [-0.8, 1.4]MMRM

Comparison: Day 7p-value: 0.78895% CI: [-1.2, 0.9]MMRM

Comparison: Day 7p-value: 0.552695% CI: [-1.8, 1]MMRM

Comparison: Day 14p-value: 0.764795% CI: [-1.1, 1.5]MMRM

Comparison: Day 14p-value: 0.8995% CI: [-1.2, 1.3]MMRM

Comparison: Day 14p-value: 0.709795% CI: [-1.9, 1.3]MMRM

Comparison: Day 21p-value: 0.460195% CI: [-0.9, 2.1]MMRM

Comparison: Day 21p-value: 0.628895% CI: [-1.8, 1.1]MMRM

Comparison: Day 21p-value: 0.609995% CI: [-2.3, 1.3]MMRM

Comparison: Day 28p-value: 0.27995% CI: [-0.7, 2.5]MMRM

Comparison: Day 28p-value: 0.425395% CI: [-2.1, 0.9]MMRM

Comparison: Day 28p-value: 0.301495% CI: [-2.9, 0.9]MMRM

Comparison: Day 35p-value: 0.97295% CI: [-1.7, 1.7]MMRM

Comparison: Day 35p-value: 0.475895% CI: [-2.2, 1]MMRM

Comparison: Day 35p-value: 0.441995% CI: [-2.8, 1.2]MMRM

Comparison: Day 42p-value: 0.476295% CI: [-2.4, 1.1]MMRM

Comparison: Day 42p-value: 0.104695% CI: [-3.1, 0.3]MMRM

Comparison: Day 42p-value: 0.141195% CI: [-3.7, 0.5]MMRM

Secondary

Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42

This measure reports results for the 7 items of the negative subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS negative subscale score for each participant was sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.

Time frame: Baseline and Days 4, 7, 14, 21, 28, 35 and 42

Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Asenapine 2.5 mg BID	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-1.6 score on a scale	Standard Error 0.37
Asenapine 2.5 mg BID	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-1.2 score on a scale	Standard Error 0.33
Asenapine 2.5 mg BID	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-3.3 score on a scale	Standard Error 0.48
Asenapine 2.5 mg BID	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-2.5 score on a scale	Standard Error 0.45
Asenapine 2.5 mg BID	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-3.3 score on a scale	Standard Error 0.54
Asenapine 2.5 mg BID	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-0.7 score on a scale	Standard Error 0.29
Asenapine 2.5 mg BID	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-2.3 score on a scale	Standard Error 0.41
Asenapine 5 mg BID	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-3.4 score on a scale	Standard Error 0.43
Asenapine 5 mg BID	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-1.3 score on a scale	Standard Error 0.31
Asenapine 5 mg BID	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-2.3 score on a scale	Standard Error 0.34
Asenapine 5 mg BID	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-2.5 score on a scale	Standard Error 0.37
Asenapine 5 mg BID	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-0.5 score on a scale	Standard Error 0.27
Asenapine 5 mg BID	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-3.1 score on a scale	Standard Error 0.4
Asenapine 5 mg BID	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-4.3 score on a scale	Standard Error 0.48
Olanzapine 15 mg QD	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-0.9 score on a scale	Standard Error 0.42
Olanzapine 15 mg QD	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-3.8 score on a scale	Standard Error 0.68
Olanzapine 15 mg QD	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-3.4 score on a scale	Standard Error 0.63
Olanzapine 15 mg QD	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-1.7 score on a scale	Standard Error 0.51
Olanzapine 15 mg QD	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-2.6 score on a scale	Standard Error 0.59
Olanzapine 15 mg QD	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-1.5 score on a scale	Standard Error 0.47
Olanzapine 15 mg QD	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-2.0 score on a scale	Standard Error 0.56
Placebo BID	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-2.3 score on a scale	Standard Error 0.4
Placebo BID	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-2.6 score on a scale	Standard Error 0.46
Placebo BID	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-1.8 score on a scale	Standard Error 0.37
Placebo BID	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-3.2 score on a scale	Standard Error 0.51
Placebo BID	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-0.8 score on a scale	Standard Error 0.29
Placebo BID	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-1.1 score on a scale	Standard Error 0.33
Placebo BID	Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-3.0 score on a scale	Standard Error 0.43

Comparison: Day 4p-value: 0.882995% CI: [-0.7, 0.8]MMRM

Comparison: Day 4p-value: 0.548895% CI: [-0.5, 1]MMRM

Comparison: Day 4p-value: 0.78395% CI: [-1.1, 0.8]MMRM

Comparison: Day 7p-value: 0.80795% CI: [-1, 0.8]MMRM

Comparison: Day 7p-value: 0.52895% CI: [-1.1, 0.6]MMRM

Comparison: Day 7p-value: 0.402595% CI: [-1.6, 0.6]MMRM

Comparison: Day 14p-value: 0.647195% CI: [-0.8, 1.2]MMRM

Comparison: Day 14p-value: 0.250495% CI: [-1.5, 0.4]MMRM

Comparison: Day 14p-value: 0.922395% CI: [-1.2, 1.3]MMRM

Comparison: Day 21p-value: 0.883995% CI: [-1, 1.2]MMRM

Comparison: Day 21p-value: 0.807795% CI: [-1.2, 0.9]MMRM

Comparison: Day 21p-value: 0.621695% CI: [-1, 1.7]MMRM

Comparison: Day 28p-value: 0.424895% CI: [-0.7, 1.7]MMRM

Comparison: Day 28p-value: 0.766795% CI: [-1.3, 1]MMRM

Comparison: Day 28p-value: 0.628295% CI: [-1.1, 1.8]MMRM

Comparison: Day 35p-value: 0.31595% CI: [-1.9, 0.6]MMRM

Comparison: Day 35p-value: 0.190895% CI: [-2, 0.4]MMRM

Comparison: Day 35p-value: 0.312895% CI: [-2.3, 0.7]MMRM

Comparison: Day 42p-value: 0.881295% CI: [-1.5, 1.3]MMRM

Comparison: Day 42p-value: 0.114395% CI: [-2.4, 0.3]MMRM

Comparison: Day 42p-value: 0.441895% CI: [-2.3, 1]MMRM

Secondary

Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42

This measure reports results for the 7 items of the positive subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS positive subscale score for each participant was sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.

Time frame: Baseline and Days 4, 7, 14, 21, 28, 35 and 42

Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Asenapine 2.5 mg BID	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-4.0 score on a scale	Standard Error 0.52
Asenapine 2.5 mg BID	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-3.4 score on a scale	Standard Error 0.45
Asenapine 2.5 mg BID	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-4.1 score on a scale	Standard Error 0.59
Asenapine 2.5 mg BID	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-5.2 score on a scale	Standard Error 0.6
Asenapine 2.5 mg BID	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-2.3 score on a scale	Standard Error 0.39
Asenapine 2.5 mg BID	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-1.2 score on a scale	Standard Error 0.29
Asenapine 2.5 mg BID	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-5.6 score on a scale	Standard Error 0.65
Asenapine 5 mg BID	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-1.6 score on a scale	Standard Error 0.28
Asenapine 5 mg BID	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-2.8 score on a scale	Standard Error 0.36
Asenapine 5 mg BID	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-5.0 score on a scale	Standard Error 0.47
Asenapine 5 mg BID	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-5.7 score on a scale	Standard Error 0.52
Asenapine 5 mg BID	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-3.9 score on a scale	Standard Error 0.4
Asenapine 5 mg BID	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-6.3 score on a scale	Standard Error 0.53
Asenapine 5 mg BID	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-7.2 score on a scale	Standard Error 0.57
Olanzapine 15 mg QD	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-3.6 score on a scale	Standard Error 0.55
Olanzapine 15 mg QD	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-4.4 score on a scale	Standard Error 0.61
Olanzapine 15 mg QD	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-5.7 score on a scale	Standard Error 0.7
Olanzapine 15 mg QD	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-2.3 score on a scale	Standard Error 0.42
Olanzapine 15 mg QD	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-6.2 score on a scale	Standard Error 0.77
Olanzapine 15 mg QD	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-7.5 score on a scale	Standard Error 0.83
Olanzapine 15 mg QD	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-6.8 score on a scale	Standard Error 0.78
Placebo BID	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 35	-5.5 score on a scale	Standard Error 0.57
Placebo BID	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 4	-1.7 score on a scale	Standard Error 0.3
Placebo BID	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 42	-5.4 score on a scale	Standard Error 0.61
Placebo BID	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 28	-5.0 score on a scale	Standard Error 0.56
Placebo BID	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 14	-3.7 score on a scale	Standard Error 0.43
Placebo BID	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 21	-4.5 score on a scale	Standard Error 0.51
Placebo BID	Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42	Day 7	-2.6 score on a scale	Standard Error 0.38

Comparison: Day 4p-value: 0.21695% CI: [-0.3, 1.3]MMRM

Comparison: Day 4p-value: 0.949495% CI: [-0.7, 0.8]MMRM

Comparison: Day 4p-value: 0.183495% CI: [-1.6, 0.3]MMRM

Comparison: Day 7p-value: 0.634795% CI: [-0.8, 1.3]MMRM

Comparison: Day 7p-value: 0.691795% CI: [-1.2, 0.8]MMRM

Comparison: Day 7p-value: 0.143195% CI: [-2.3, 0.3]MMRM

Comparison: Day 14p-value: 0.626795% CI: [-0.9, 1.5]MMRM

Comparison: Day 14p-value: 0.72695% CI: [-1.3, 0.9]MMRM

Comparison: Day 14p-value: 0.332695% CI: [-2.2, 0.7]MMRM

Comparison: Day 21p-value: 0.457595% CI: [-0.9, 1.9]MMRM

Comparison: Day 21p-value: 0.49395% CI: [-1.8, 0.9]MMRM

Comparison: Day 21p-value: 0.188695% CI: [-2.8, 0.6]MMRM

Comparison: Day 28p-value: 0.264395% CI: [-0.7, 2.5]MMRM

Comparison: Day 28p-value: 0.351695% CI: [-2.2, 0.8]MMRM

Comparison: Day 28p-value: 0.206895% CI: [-3.1, 0.7]MMRM

Comparison: Day 35p-value: 0.728495% CI: [-1.3, 1.9]MMRM

Comparison: Day 35p-value: 0.269895% CI: [-2.4, 0.7]MMRM

Comparison: Day 35p-value: 0.15195% CI: [-3.3, 0.5]MMRM

Comparison: Day 42p-value: 0.803995% CI: [-2, 1.5]MMRM

Comparison: Day 42p-value: 0.030695% CI: [-3.5, -0.2]MMRM

Comparison: Day 42p-value: 0.040695% CI: [-4.1, -0.1]MMRM

Secondary

Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35

The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline; improvement in symptoms is represented by negative values.

Time frame: Baseline and Days 4, 7, 14, 21, 28 and 35

Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Asenapine 2.5 mg BID	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 14	-9.9 score on a scale	Standard Error 1.31
Asenapine 2.5 mg BID	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 35	-17.0 score on a scale	Standard Error 1.66
Asenapine 2.5 mg BID	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 28	-12.3 score on a scale	Standard Error 1.69
Asenapine 2.5 mg BID	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 21	-12.0 score on a scale	Standard Error 1.55
Asenapine 2.5 mg BID	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 7	-7.2 score on a scale	Standard Error 1.17
Asenapine 2.5 mg BID	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 4	-4.0 score on a scale	Standard Error 0.8
Asenapine 5 mg BID	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 28	-17.1 score on a scale	Standard Error 1.49
Asenapine 5 mg BID	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 4	-4.9 score on a scale	Standard Error 0.76
Asenapine 5 mg BID	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 7	-9.1 score on a scale	Standard Error 1.09
Asenapine 5 mg BID	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 14	-12.5 score on a scale	Standard Error 1.19
Asenapine 5 mg BID	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 21	-14.8 score on a scale	Standard Error 1.4
Asenapine 5 mg BID	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 35	-19.0 score on a scale	Standard Error 1.48
Olanzapine 15 mg QD	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 21	-15.2 score on a scale	Standard Error 2.09
Olanzapine 15 mg QD	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 14	-12.4 score on a scale	Standard Error 1.8
Olanzapine 15 mg QD	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 28	-17.3 score on a scale	Standard Error 2.21
Olanzapine 15 mg QD	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 4	-5.5 score on a scale	Standard Error 1.15
Olanzapine 15 mg QD	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 35	-20.3 score on a scale	Standard Error 2.19
Olanzapine 15 mg QD	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 7	-9.3 score on a scale	Standard Error 1.67
Placebo BID	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 7	-7.1 score on a scale	Standard Error 1.16
Placebo BID	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 21	-13.2 score on a scale	Standard Error 1.5
Placebo BID	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 14	-10.7 score on a scale	Standard Error 1.28
Placebo BID	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 35	-15.4 score on a scale	Standard Error 1.58
Placebo BID	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 28	-15.5 score on a scale	Standard Error 1.61
Placebo BID	Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35	Day 4	-4.8 score on a scale	Standard Error 0.81

Comparison: Day 4p-value: 0.484995% CI: [-1.4, 2.9]MMRM

Comparison: Day 4p-value: 0.890295% CI: [-2.2, 1.9]MMRM

Comparison: Day 4p-value: 0.582695% CI: [-3.4, 1.9]MMRM

Comparison: Day 7p-value: 0.927195% CI: [-3.3, 3]MMRM

Comparison: Day 7p-value: 0.190295% CI: [-5.1, 1]MMRM

Comparison: Day 7p-value: 0.27195% CI: [-6.2, 1.7]MMRM

Comparison: Day 14p-value: 0.677395% CI: [-2.8, 4.3]MMRM

Comparison: Day 14p-value: 0.289595% CI: [-5.2, 1.6]MMRM

Comparison: Day 14p-value: 0.426195% CI: [-6, 2.6]MMRM

Comparison: Day 21p-value: 0.550595% CI: [-2.9, 5.5]MMRM

Comparison: Day 21p-value: 0.428695% CI: [-5.6, 2.4]MMRM

Comparison: Day 21p-value: 0.442395% CI: [-7, 3.1]MMRM

Comparison: Day 28p-value: 0.169195% CI: [-1.4, 7.7]MMRM

Comparison: Day 28p-value: 0.468295% CI: [-5.8, 2.7]MMRM

Comparison: Day 28p-value: 0.496195% CI: [-7.2, 3.5]MMRM

Comparison: Day 35p-value: 0.469795% CI: [-6.1, 2.8]MMRM

Comparison: Day 35p-value: 0.094795% CI: [-7.8, 0.6]MMRM

Comparison: Day 35p-value: 0.067595% CI: [-10.2, 0.4]MMRM

Secondary

Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42

A CGI-I responder was defined as a participant who had a CGI-I score of 1 (very much improved) or 2 (much improved) at a post-baseline assessment. CGI-I is a 7-point scale for assessing the global improvement of the participant's illness relative to baseline, with ratings from 1=very much improved to 7=very much worse. Missing data were imputed by LOCF.

Time frame: Days 4, 7, 14, 21, 28, 35 and 42

Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score

Arm	Measure	Group	Value (NUMBER)	Dispersion
Asenapine 2.5 mg BID	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 4 (n = 95,108,44,98)	34.7 percentage of participants	0.27
Asenapine 2.5 mg BID	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 28 (n = 96,111,45,99)	58.3 percentage of participants	0.36
Asenapine 2.5 mg BID	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 21 (n = 96,111,45,99)	54.2 percentage of participants	0.32
Asenapine 2.5 mg BID	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 35 (n = 96,111,45,99)	60.4 percentage of participants	0.34
Asenapine 2.5 mg BID	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 7 (n = 96,111,45,99)	51.0 percentage of participants	0.3
Asenapine 2.5 mg BID	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 42 (n = 96,111,45,99)	59.4 percentage of participants	0.4
Asenapine 2.5 mg BID	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 14 (n = 96,111,45,99)	51.0 percentage of participants	0.31
Asenapine 5 mg BID	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 28 (n = 96,111,45,99)	62.2 percentage of participants	0.32
Asenapine 5 mg BID	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 4 (n = 95,108,44,98)	33.3 percentage of participants	0.25
Asenapine 5 mg BID	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 7 (n = 96,111,45,99)	46.8 percentage of participants	0.28
Asenapine 5 mg BID	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 21 (n = 96,111,45,99)	63.1 percentage of participants	0.29
Asenapine 5 mg BID	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 42 (n = 96,111,45,99)	66.7 percentage of participants	0.35
Asenapine 5 mg BID	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 14 (n = 96,111,45,99)	60.4 percentage of participants	0.28
Asenapine 5 mg BID	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 35 (n = 96,111,45,99)	64.0 percentage of participants	0.3
Olanzapine 15 mg QD	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 28 (n = 96,111,45,99)	73.3 percentage of participants	0.47
Olanzapine 15 mg QD	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 7 (n = 96,111,45,99)	60.0 percentage of participants	0.43
Olanzapine 15 mg QD	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 35 (n = 96,111,45,99)	82.2 percentage of participants	0.44
Olanzapine 15 mg QD	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 42 (n = 96,111,45,99)	84.4 percentage of participants	0.5
Olanzapine 15 mg QD	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 21 (n = 96,111,45,99)	75.6 percentage of participants	0.42
Olanzapine 15 mg QD	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 4 (n = 95,108,44,98)	43.2 percentage of participants	0.38
Olanzapine 15 mg QD	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 14 (n = 96,111,45,99)	71.1 percentage of participants	0.42
Placebo BID	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 14 (n = 96,111,45,99)	54.5 percentage of participants	0.3
Placebo BID	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 7 (n = 96,111,45,99)	45.5 percentage of participants	0.3
Placebo BID	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 28 (n = 96,111,45,99)	60.6 percentage of participants	0.35
Placebo BID	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 4 (n = 95,108,44,98)	37.8 percentage of participants	0.27
Placebo BID	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 42 (n = 96,111,45,99)	62.6 percentage of participants	0.38
Placebo BID	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 35 (n = 96,111,45,99)	64.6 percentage of participants	0.32
Placebo BID	Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42	Day 21 (n = 96,111,45,99)	58.6 percentage of participants	0.31

Comparison: Day 4p-value: 0.6205Cochran-Mantel-Haenszel

Comparison: Day 4p-value: 0.4829Cochran-Mantel-Haenszel

Comparison: Day 4p-value: 0.3945Cochran-Mantel-Haenszel

Comparison: Day 7p-value: 0.4076Cochran-Mantel-Haenszel

Comparison: Day 7p-value: 0.969Cochran-Mantel-Haenszel

Comparison: Day 7p-value: 0.117Cochran-Mantel-Haenszel

Comparison: Day 14p-value: 0.5088Cochran-Mantel-Haenszel

Comparison: Day 14p-value: 0.3426Cochran-Mantel-Haenszel

Comparison: Day 14p-value: 0.0762Cochran-Mantel-Haenszel

Comparison: Day 21p-value: 0.5531Cochran-Mantel-Haenszel

Comparison: Day 21p-value: 0.4875Cochran-Mantel-Haenszel

Comparison: Day 21p-value: 0.0692Cochran-Mantel-Haenszel

Comparison: Day 28p-value: 0.7482Cochran-Mantel-Haenszel

Comparison: Day 28p-value: 0.8037Cochran-Mantel-Haenszel

Comparison: Day 28p-value: 0.0859Cochran-Mantel-Haenszel

Comparison: Day 35p-value: 0.585Cochran-Mantel-Haenszel

Comparison: Day 35p-value: 0.9698Cochran-Mantel-Haenszel

Comparison: Day 35p-value: 0.0132Cochran-Mantel-Haenszel

Comparison: Day 42p-value: 0.7129Cochran-Mantel-Haenszel

Comparison: Day 42p-value: 0.5074Cochran-Mantel-Haenszel

Comparison: Day 42p-value: 0.004Cochran-Mantel-Haenszel

Secondary

Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42

Rate of PANSS responders at Day 42 is a Key Secondary Outcome Measure. A PANSS responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS total score at a post-baseline assessment. The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. Missing data were imputed by Last Observation Carried Forward (LOCF).

Time frame: Baseline and Day 42

Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score

Arm	Measure	Value (NUMBER)	Dispersion
Asenapine 2.5 mg BID	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42	14.6 percentage of participants	0.11
Asenapine 5 mg BID	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42	25.2 percentage of participants	0.1
Olanzapine 15 mg QD	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42	26.7 percentage of participants	0.14
Placebo BID	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42	19.2 percentage of participants	0.11

p-value: 0.262Cochran-Mantel-Haenszel

Secondary

Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35

A PANSS responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS total score at a post-baseline assessment. The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF.

Time frame: Days 4, 7, 14, 21, 28 and 35

Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score

Arm	Measure	Group	Value (NUMBER)	Dispersion
Asenapine 2.5 mg BID	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 35 (n = 96,111,45,99)	15.6 percentage of participants	0.34
Asenapine 2.5 mg BID	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 4 (n = 95,108,44,97)	0.0 percentage of participants	0.27
Asenapine 2.5 mg BID	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 28 (n = 96,111,45,99)	10.4 percentage of participants	0.36
Asenapine 2.5 mg BID	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 21 (n = 96,111,45,99)	8.3 percentage of participants	0.32
Asenapine 2.5 mg BID	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 7 (n = 96,111,45,99)	2.1 percentage of participants	0.3
Asenapine 2.5 mg BID	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 14 (n = 96,111,45,99)	5.2 percentage of participants	0.31
Asenapine 5 mg BID	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 28 (n = 96,111,45,99)	16.2 percentage of participants	0.32
Asenapine 5 mg BID	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 4 (n = 95,108,44,97)	0.0 percentage of participants	0.25
Asenapine 5 mg BID	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 14 (n = 96,111,45,99)	5.4 percentage of participants	0.28
Asenapine 5 mg BID	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 7 (n = 96,111,45,99)	5.4 percentage of participants	0.28
Asenapine 5 mg BID	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 21 (n = 96,111,45,99)	14.4 percentage of participants	0.29
Asenapine 5 mg BID	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 35 (n = 96,111,45,99)	21.6 percentage of participants	0.3
Olanzapine 15 mg QD	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 7 (n = 96,111,45,99)	0.0 percentage of participants	0.43
Olanzapine 15 mg QD	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 35 (n = 96,111,45,99)	15.6 percentage of participants	0.44
Olanzapine 15 mg QD	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 4 (n = 95,108,44,97)	0.0 percentage of participants	0.38
Olanzapine 15 mg QD	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 21 (n = 96,111,45,99)	11.1 percentage of participants	0.42
Olanzapine 15 mg QD	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 28 (n = 96,111,45,99)	15.6 percentage of participants	0.47
Olanzapine 15 mg QD	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 14 (n = 96,111,45,99)	4.4 percentage of participants	0.42
Placebo BID	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 14 (n = 96,111,45,99)	7.1 percentage of participants	0.3
Placebo BID	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 28 (n = 96,111,45,99)	14.1 percentage of participants	0.35
Placebo BID	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 35 (n = 96,111,45,99)	17.2 percentage of participants	0.32
Placebo BID	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 7 (n = 96,111,45,99)	5.1 percentage of participants	0.3
Placebo BID	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 4 (n = 95,108,44,97)	2.1 percentage of participants	0.27
Placebo BID	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35	Day 21 (n = 96,111,45,99)	13.1 percentage of participants	0.31

Comparison: Day 4p-value: 0.1736Cochran-Mantel-Haenszel

Comparison: Day 4p-value: 0.285Cochran-Mantel-Haenszel

Comparison: Day 7p-value: 0.329Cochran-Mantel-Haenszel

Comparison: Day 7p-value: 0.6938Cochran-Mantel-Haenszel

Comparison: Day 7p-value: 0.1105Cochran-Mantel-Haenszel

Comparison: Day 14p-value: 0.6804Cochran-Mantel-Haenszel

Comparison: Day 14p-value: 0.9704Cochran-Mantel-Haenszel

Comparison: Day 14p-value: 0.6604Cochran-Mantel-Haenszel

Comparison: Day 21p-value: 0.2447Cochran-Mantel-Haenszel

Comparison: Day 21p-value: 0.4834Cochran-Mantel-Haenszel

Comparison: Day 21p-value: 0.9189Cochran-Mantel-Haenszel

Comparison: Day 28p-value: 0.437Cochran-Mantel-Haenszel

Comparison: Day 28p-value: 0.2894Cochran-Mantel-Haenszel

Comparison: Day 28p-value: 0.6953Cochran-Mantel-Haenszel

Comparison: Day 35p-value: 0.4892Cochran-Mantel-Haenszel

Comparison: Day 35p-value: 0.1954Cochran-Mantel-Haenszel

Comparison: Day 35p-value: 0.799Cochran-Mantel-Haenszel

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

A Study of the Efficacy and Safety of Asenapine in Participants With an Acute Exacerbation of Schizophrenia (P05688)

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Change From Baseline in PANSS Total Score at Day 42

Change From Baseline in Body Weight at Day 42

Change From Baseline in CGI-S Score at Day 42

Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35

Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42

Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42

Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42

Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42

Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42

Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42

Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42

Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42

Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35

Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42

Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42

Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35