Trial · NCT02634346

A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)

NCT02634346, Phase 3, Completed, Alkermes, Inc.; results first posted 2018-06-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study). Trials, record NCT02634346. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02634346

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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 Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)
NCT number: NCT02634346
Status: Completed
Phases: Phase 3
Enrollment: 403 participants, actual
Lead sponsor: Alkermes, Inc.
Conditions: Schizophrenia
Interventions: ALK3831, Olanzapine, Placebo
First posted: 2015-12-18
Last updated: 2018-06-27
Results first posted: 2018-06-27
Limitations and caveats: The dose of olanzapine was not fixed and could be titrated during the first 2 weeks of the study.

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4	4 weeks	This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and Week 4.
Secondary	Change From Baseline in Clinical Global Impressions-Severity (CGIS) Score at Week 4	4 weeks	The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients". Results indicate a change in CGI-S score from baseline to Week 4 based on the observed data. Change is calculated between the baseline visit and Week 4.
Secondary	Incidence of Adverse Events	Approximately 4 weeks

Source ClinicalTrials.gov

Outcomes3

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 Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4	4 weeks	Subjects that received at least 1 dose of study drug and had at least 1 post-baseline PANSS assessment.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Clinical Global Impressions-Severity (CGIS) Score at Week 4	4 weeks	Subjects who received at least 1 dose of study drug and had at least 1 post-baseline PANSS assessment.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Incidence of Adverse Events	Approximately 4 weeks	Number of subjects who received study drug and had a treatment-emergent adverse event	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group9

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4	ALKS 3831	-23.9	Standard Error 1.28	units on a scale
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4	Olanzapine	-22.8	Standard Error 1.29	units on a scale
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4	Placebo	-17.5	Standard Error 1.32	units on a scale
Change From Baseline in Clinical Global Impressions-Severity (CGIS) Score at Week 4	ALKS 3831	-1.21	Standard Error 0.082	units on a scale
Change From Baseline in Clinical Global Impressions-Severity (CGIS) Score at Week 4	Olanzapine	-1.27	Standard Error 0.083	units on a scale
Change From Baseline in Clinical Global Impressions-Severity (CGIS) Score at Week 4	Placebo	-0.84	Standard Error 0.085	units on a scale
Incidence of Adverse Events	ALKS 3831	73		Participants
Incidence of Adverse Events	Olanzapine	73		Participants
Incidence of Adverse Events	Placebo	60		Participants

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	ALKS 3831	134
Overall Study	STARTED	Olanzapine	133
Overall Study	STARTED	Placebo	134
Overall Study	COMPLETED	ALKS 3831	122
Overall Study	COMPLETED	Olanzapine	119
Overall Study	COMPLETED	Placebo	111
Overall Study	NOT COMPLETED	ALKS 3831	12
Overall Study	NOT COMPLETED	Olanzapine	14
Overall Study	NOT COMPLETED	Placebo	23

Source ClinicalTrials.gov

Adverse events24

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	Weight increased	Investigations	ALKS 3831	25	134	25
other	Weight increased	Investigations	Olanzapine	19	133	19
other	Weight increased	Investigations	Placebo	4	134	4
other	Somnolence	Nervous system disorders	ALKS 3831	12	134	12
other	Somnolence	Nervous system disorders	Olanzapine	13	133	13
other	Somnolence	Nervous system disorders	Placebo	3	134	3
other	Dry mouth	Gastrointestinal disorders	ALKS 3831	10	134	10
other	Dry mouth	Gastrointestinal disorders	Olanzapine	7	133	8
other	Dry mouth	Gastrointestinal disorders	Placebo	1	134	1
other	Anxiety	Psychiatric disorders	ALKS 3831	8	134	8

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ALKS 3831	0	134
Total, all-cause mortality	Olanzapine	1	133
Total, all-cause mortality	Placebo	0	134
Total, other adverse events	ALKS 3831	50	134
Total, other adverse events	Olanzapine	45	133
Total, other adverse events	Placebo	24	134
Total, serious adverse events	ALKS 3831	1	134
Total, serious adverse events	Olanzapine	1	133
Total, serious adverse events	Placebo	0	134

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32141723	DERIVED	PubMed
41944743	DERIVED	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/NCT02634346

GET https://conductscience.org/api/trials/v1/NCT02634346/events?page=2

API reference For AI assistants