Trial · NCT01617187

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

NCT01617187, Phase 3, Completed, Organon and Co; results first posted 2015-08-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of the Efficacy and Safety of Asenapine in Participants With an Acute Exacerbation of Schizophrenia (P05688). Trials, record NCT01617187. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01617187

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of the Efficacy and Safety of Asenapine in Participants With an Acute Exacerbation of Schizophrenia (P05688)
NCT number: NCT01617187
Status: Completed
Phases: Phase 3
Enrollment: 360 participants, actual
Lead sponsor: Organon and Co
Conditions: Schizophrenia
Interventions: Asenapine, Placebo Asenapine, Olanzapine, Placebo Olanzapine
First posted: 2012-06-12
Last updated: 2024-06-18
Other registries' IDs: eudract:2010-018407-28
Results first posted: 2015-08-31

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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.
Secondary	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).
Secondary	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.
Secondary	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.
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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in PANSS Total Score at Day 42	Baseline and Day 42	FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in CGI-S Score at Day 42	Baseline and Day 42	FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42	Baseline and Day 42	FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Body Weight at Day 42	Baseline and Day 42	All randomized participants who received ≥1 dose of study drug	kg	LEAST_SQUARES_MEAN
SECONDARY	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	FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score	score on a scale	LEAST_SQUARES_MEAN
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	Days 4, 7, 14, 21, 28 and 35	FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score	percentage of participants	NUMBER
SECONDARY	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	FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	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	FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score	percentage of participants	NUMBER
SECONDARY	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	FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	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	FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score	score on a scale	LEAST_SQUARES_MEAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group340

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in PANSS Total Score at Day 42	Asenapine 2.5 mg BID	-17.4	Standard Error 1.80	score on a scale
Change From Baseline in PANSS Total Score at Day 42	Asenapine 5 mg BID	-21.7	Standard Error 1.60	score on a scale
Change From Baseline in PANSS Total Score at Day 42	Olanzapine 15 mg QD	-21.6	Standard Error 2.32	score on a scale
Change From Baseline in PANSS Total Score at Day 42	Placebo BID	-16.2	Standard Error 1.71	score on a scale
Change From Baseline in CGI-S Score at Day 42	Asenapine 2.5 mg BID	-0.9	Standard Error 0.11	score on a scale
Change From Baseline in CGI-S Score at Day 42	Asenapine 5 mg BID	-1.2	Standard Error 0.10	score on a scale
Change From Baseline in CGI-S Score at Day 42	Olanzapine 15 mg QD	-1.1	Standard Error 0.14	score on a scale
Change From Baseline in CGI-S Score at Day 42	Placebo BID	-1.0	Standard Error 0.11	score on a scale
Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42	Asenapine 2.5 mg BID	14.6	0.11	percentage of participants
Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42	Asenapine 5 mg BID	25.2	0.10	percentage of participants

1 to 10 of 340Source ClinicalTrials.gov

See all 340 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Randomization Through Start Treatment	STARTED	Asenapine 2.5 mg BID	98
Randomization Through Start Treatment	STARTED	Asenapine 5 mg BID	113
Randomization Through Start Treatment	STARTED	Olanzapine 15 mg QD	46
Randomization Through Start Treatment	STARTED	Placebo BID	103
Randomization Through Start Treatment	COMPLETED	Asenapine 2.5 mg BID	97
Randomization Through Start Treatment	COMPLETED	Asenapine 5 mg BID	113
Randomization Through Start Treatment	COMPLETED	Olanzapine 15 mg QD	46
Randomization Through Start Treatment	COMPLETED	Placebo BID	101
Randomization Through Start Treatment	NOT COMPLETED	Asenapine 2.5 mg BID	1
Randomization Through Start Treatment	NOT COMPLETED	Asenapine 5 mg BID	0

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events96

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	Asenapine 2.5 mg BID	0	97	0
other	Diarrhoea	Gastrointestinal disorders	Asenapine 5 mg BID	2	113	2
other	Diarrhoea	Gastrointestinal disorders	Olanzapine 15 mg QD	3	46	3
other	Diarrhoea	Gastrointestinal disorders	Placebo BID	2	101	2
other	Dry mouth	Gastrointestinal disorders	Asenapine 2.5 mg BID	0	97	0
other	Dry mouth	Gastrointestinal disorders	Asenapine 5 mg BID	2	113	2
other	Dry mouth	Gastrointestinal disorders	Olanzapine 15 mg QD	5	46	5
other	Dry mouth	Gastrointestinal disorders	Placebo BID	1	101	1
other	Dyspepsia	Gastrointestinal disorders	Asenapine 2.5 mg BID	1	97	1
other	Dyspepsia	Gastrointestinal disorders	Asenapine 5 mg BID	2	113	2

1 to 10 of 96Source ClinicalTrials.gov

See all 96 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Asenapine 2.5 mg BID
Total, all-cause mortality	Asenapine 5 mg BID
Total, all-cause mortality	Olanzapine 15 mg QD
Total, all-cause mortality	Placebo BID
Total, other adverse events	Asenapine 2.5 mg BID	27	97
Total, other adverse events	Asenapine 5 mg BID	47	113
Total, other adverse events	Olanzapine 15 mg QD	17	46
Total, other adverse events	Placebo BID	29	101
Total, serious adverse events	Asenapine 2.5 mg BID	5	97
Total, serious adverse events	Asenapine 5 mg BID	5	113

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27821210	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01617187

GET https://conductscience.org/api/trials/v1/NCT01617187/results?page=2

API reference For AI assistants