Trial · NCT01903837

A Study of ALKS 3831 in Adults With Schizophrenia

NCT01903837, Phase 2, Completed, Alkermes, Inc.; results first posted 2021-09-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of ALKS 3831 in Adults With Schizophrenia. Trials, record NCT01903837. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01903837

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Trial

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

Title: A Study of ALKS 3831 in Adults With Schizophrenia
NCT number: NCT01903837
Status: Completed
Phases: Phase 2
Enrollment: 347 participants, actual
Lead sponsor: Alkermes, Inc.
Conditions: Schizophrenia
Interventions: Samidorphan (Low Dose), Samidorphan (Medium Dose), Samidorphan (High Dose), Placebo, Olanzapine
First posted: 2013-07-19
Last updated: 2021-10-06
Results first posted: 2021-09-08

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score	Baseline (Day 8) to Day 92 (end of study Part A)	Change from baseline (Day 8) to Day 92 (end of study Part A). The PANSS is a 30-item scale measuring severity of schizophrenia symptoms. Symptom severity for each item is rated on a 7-point scale (1 = absent; 7 = extreme), and the total score is added together, with a minimum score of 30 and a maximum score of 210. A higher score indicates more severe symptoms, while a lower score indicates less severe symptoms.
Secondary	Percent Change in Body Weight (Kilogram) From Baseline to Day 92	Baseline (Day 8) to Day 92 (end of study Part A)	Percent change from baseline (Day 8) to the end of Part A (Day 92)
Secondary	Absolute Change in Body Weight (kg) From Baseline to Day 92	Baseline (Day 8) to Day 92 (end of study Part A)	Change from randomization (Day 8) to the end of Part A (Week 12; Day 92)
Secondary	Percentage of Subjects Exhibiting Significant Weight Gain at Day 92	Baseline (Day 8) to Day 92 (end of study Part A)	Significant weight gain will include a \>=5%, \>= 7%, or \>=10% gain in body weight from baseline (Day 8) to Day 92 (end of study Part A)
Secondary	Change in Clinical Global Impressions - Severity (CGI-S) From Baseline to Day 92	Baseline (Day 8) to Day 92 (end of study Part A)	Change in CGI-S score from baseline (Day 8) to the end of Part A (Week 12; Day 92). The CGI-S is a 7-point scale intended to measure the severity of a patient's illness at the time of assessment. Scores range from 1 (normal) to 7(extremely ill), so a higher score is correlative to more severe illness.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score	Baseline (Day 8) to Day 92 (end of study Part A)	Full Analysis Set (FAS) 1 efficacy analysis population included all randomized subjects who received at least one dose of study drug and had at least one postbaseline assessment of Positive and Negative Syndrome Scale (PANSS) total score.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percent Change in Body Weight (Kilogram) From Baseline to Day 92	Baseline (Day 8) to Day 92 (end of study Part A)	Full Analysis Set (FAS) 1 efficacy analysis population included all randomized subjects who received at least one dose of study drug and had at least one postbaseline assessment of Positive and Negative Syndrome Scale (PANSS) total score. FAS 2 efficacy analysis population included all FAS 1 subjects who gained weight during the 1-week OLZ lead-in period prior to randomization and had at least one postbaseline weight assessment.	percent change	LEAST_SQUARES_MEAN
SECONDARY	Absolute Change in Body Weight (kg) From Baseline to Day 92	Baseline (Day 8) to Day 92 (end of study Part A)	Full Analysis Set (FAS) 1 efficacy analysis population included all randomized subjects who received at least one dose of study drug and had at least one postbaseline assessment of Positive and Negative Syndrome Scale (PANSS) total score. FAS 2 efficacy analysis population included all FAS 1 subjects who gained weight during the 1-week OLZ lead-in period prior to randomization and had at least one postbaseline weight assessment.	kg	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Subjects Exhibiting Significant Weight Gain at Day 92	Baseline (Day 8) to Day 92 (end of study Part A)	Full Analysis Set (FAS) 1 efficacy analysis population included all randomized subjects who received at least one dose of study drug and had at least one postbaseline assessment of Positive and Negative Syndrome Scale (PANSS) total score. FAS 2 efficacy analysis population included all FAS 1 subjects who gained weight during the 1-week OLZ lead-in period prior to randomization and had at least one postbaseline weight assessment.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Clinical Global Impressions - Severity (CGI-S) From Baseline to Day 92	Baseline (Day 8) to Day 92 (end of study Part A)	Full Analysis Set (FAS) 1 efficacy analysis population included all randomized subjects who received at least one dose of study drug and had at least one postbaseline assessment of Positive and Negative Syndrome Scale (PANSS) total score.	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group48

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

Outcome	Group	Value	Spread	Units
Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score	Part A FAS 1 - Olz + Placebo	-2.9	Standard Error 0.82	units on a scale
Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score	Part A FAS 1 - Olz + Sam 5mg	-1.5	Standard Error 0.85	units on a scale
Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score	Part A FAS 1- Olz+ Sam 10mg	-2.7	Standard Error 0.79	units on a scale
Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score	Part A FAS 1- Olz+ Sam 20mg	-2.5	Standard Error 0.83	units on a scale
Percent Change in Body Weight (Kilogram) From Baseline to Day 92	Part A FAS 1 - Olz + Placebo	4.1	95% Confidence Interval 3.2 to 5.0	percent change
Percent Change in Body Weight (Kilogram) From Baseline to Day 92	Part A FAS 1 - Olz + Sam 5mg	2.8	95% Confidence Interval 1.8 to 3.7	percent change
Percent Change in Body Weight (Kilogram) From Baseline to Day 92	Part A FAS 1- Olz + Sam 10mg	2.1	95% Confidence Interval 1.3 to 3.0	percent change
Percent Change in Body Weight (Kilogram) From Baseline to Day 92	Part A FAS 1- Olz + Sam 20mg	2.9	95% Confidence Interval 1.9 to 3.8	percent change
Percent Change in Body Weight (Kilogram) From Baseline to Day 92	Part A FAS 2- Olz + Placebo	5.3	95% Confidence Interval 4.2 to 6.4	percent change
Percent Change in Body Weight (Kilogram) From Baseline to Day 92	Part A FAS 2- Olz + Sam 5mg	3.8	95% Confidence Interval 2.7 to 4.9	percent change

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow24

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

Period	Milestone	Group	Participants
Part A	STARTED	Olz + Placebo/ Olz+Sam 20mg	75
Part A	STARTED	Olz + Sam 5mg / Olz + Sam 5mg	80
Part A	STARTED	Olz + Sam 10mg /Olz + Sam 10mg	86
Part A	STARTED	Olz + Sam 20mg/ Olz + Sam 20mg	68
Part A	COMPLETED	Olz + Placebo/ Olz+Sam 20mg	56
Part A	COMPLETED	Olz + Sam 5mg / Olz + Sam 5mg	52
Part A	COMPLETED	Olz + Sam 10mg /Olz + Sam 10mg	58
Part A	COMPLETED	Olz + Sam 20mg/ Olz + Sam 20mg	55
Part A	NOT COMPLETED	Olz + Placebo/ Olz+Sam 20mg	19
Part A	NOT COMPLETED	Olz + Sam 5mg / Olz + Sam 5mg	28

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events176

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
other	Weight increased	Investigations	Part A- Olz + Placebo	9	75
other	Weight increased	Investigations	Part A-Olz + Sam 5mg	8	80
other	Weight increased	Investigations	Part A- Olz + Sam 10mg	9	86
other	Weight increased	Investigations	Part A- Olz + Sam 20mg	6	68
other	Weight increased	Investigations	Part B-Olz +Placebo/ Olz+Sam 20mg	3	54
other	Weight increased	Investigations	Part B- Olz + Sam 5mg / Olz +Sam 5mg	6	52
other	Weight increased	Investigations	Part B- Olz + Sam 10mg/ Olz + Sam 10mg	2	57
other	Weight increased	Investigations	Part B-Olz + Sam 20mg/ Olz + Sam 20mg	3	55
other	Weight decreased	Investigations	Part A- Olz + Placebo	0	75
other	Weight decreased	Investigations	Part A-Olz + Sam 5mg	0	80

1 to 10 of 176Source ClinicalTrials.gov

See all 176 adverse events

Adverse event totals24

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Part A- Olz + Placebo	0	75
Total, all-cause mortality	Part A-Olz + Sam 5mg	0	80
Total, all-cause mortality	Part A- Olz + Sam 10mg	0	86
Total, all-cause mortality	Part A- Olz + Sam 20mg	0	68
Total, all-cause mortality	Part B-Olz +Placebo/ Olz+Sam 20mg	0	54
Total, all-cause mortality	Part B- Olz + Sam 5mg / Olz +Sam 5mg	0	52
Total, all-cause mortality	Part B- Olz + Sam 10mg/ Olz + Sam 10mg	0	57
Total, all-cause mortality	Part B-Olz + Sam 20mg/ Olz + Sam 20mg	0	55
Total, other adverse events	Part A- Olz + Placebo	33	75
Total, other adverse events	Part A-Olz + Sam 5mg	25	80

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30845818	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/NCT01903837

GET https://conductscience.org/api/trials/v1/NCT01903837/results?page=2

API reference For AI assistants