Trial · NCT03201757

Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831

NCT03201757, Phase 3, Completed, Alkermes, Inc.; results first posted 2024-09-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831. Trials, record NCT03201757. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03201757

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Trial

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

Title: Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831
NCT number: NCT03201757
Status: Completed
Phases: Phase 3
Enrollment: 523 participants, actual
Lead sponsor: Alkermes, Inc.
Conditions: Schizophrenia, Schizophreniform Disorder, Bipolar I Disorder
Interventions: ALKS 3831
First posted: 2017-06-28
Last updated: 2024-09-26
Results first posted: 2024-09-26

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Incidence of Adverse Events	Up to 48 months
Primary	Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale	Up to 48 months	The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis; 1 being normal, not ill at all and 7 being among the severally ill patients

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence of Adverse Events	Up to 48 months	All enrolled participants who received at least 1 dose of study drug	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale	Up to 48 months		units on a scale	MEAN

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Incidence of Adverse Events	ALKS 3831		314		Participants
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale	ALKS 3831		-.24	Standard Deviation .651	units on a scale

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	ALKS 3831	523
Overall Study	COMPLETED	ALKS 3831	188
Overall Study	NOT COMPLETED	ALKS 3831	335

Source ClinicalTrials.gov

Adverse events60

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	ALKS 3831	51	523
other	Headache	Nervous system disorders	ALKS 3831	37	523
other	Anxiety	Psychiatric disorders	ALKS 3831	32	523
other	Insomnia	Psychiatric disorders	ALKS 3831	31	523
other	Nausea	Gastrointestinal disorders	ALKS 3831	30	523
other	Weight decreased	Investigations	ALKS 3831	30	523
other	Blood creatine phosphokinase increased	Investigations	ALKS 3831	22	523
other	Nasopharyngitis	Infections and infestations	ALKS 3831	17	523
other	Schizophrenia	Psychiatric disorders	ALKS 3831	15	523
other	Vomiting	Gastrointestinal disorders	ALKS 3831	15	523

1 to 10 of 60Source ClinicalTrials.gov

See all 60 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ALKS 3831	1	523
Total, other adverse events	ALKS 3831	314	523
Total, serious adverse events	ALKS 3831	35	523

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39630083	DERIVED

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/NCT03201757

GET https://conductscience.org/api/trials/v1/NCT03201757/events?page=2

API reference For AI assistants