Trial · NCT02670551

Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression

NCT02670551, Phase 3, Completed, Forest Laboratories; results first posted 2019-01-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression. Trials, record NCT02670551. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02670551

On this page

Trial

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

Title: Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression
NCT number: NCT02670551
Status: Completed
Phases: Phase 3
Enrollment: 488 participants, actual
Lead sponsor: Forest Laboratories
Conditions: Bipolar Disorder, Depression
Interventions: Cariprazine, Placebo
First posted: 2016-02-01
Last updated: 2019-01-30
Other registries' IDs: eudract:2016-000757-13
Results first posted: 2019-01-30

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Week 6	Baseline (Week 0) to Week 6	The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants were rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each of the 10 items was scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement.
Secondary	Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 6	Baseline (Week 0) to Week 6	The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of other participants the physician has observed. The participant was rated on a scale from 1 to 7, with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A negative change from Baseline indicates improvement.

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	Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Week 6	Baseline (Week 0) to Week 6	The Intent-to-Treat (ITT) Population included all participants from the safety population who had at least 1 postbaseline assessment of the MADRS total score. Overall number of participants analyzed is the number of participants with data available for analysis at the given time-point.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 6	Baseline (Week 0) to Week 6	ITT Population included all participants from the safety population who had at least 1 postbaseline assessment of the MADRS total score. Overall number of participants analyzed is the number of participants with data available for analysis at the given time-point.	score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Week 6	Placebo	-12.6	Standard Error 0.76	score on a scale
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Week 6	Cariprazine 1.5 mg	-15.1	Standard Error 0.77	score on a scale
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Week 6	Cariprazine 3.0 mg	-15.6	Standard Error 0.76	score on a scale
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 6	Placebo	-1.3	Standard Error 0.09	score on a scale
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 6	Cariprazine 1.5 mg	-1.6	Standard Error 0.10	score on a scale
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 6	Cariprazine 3.0 mg	-1.6	Standard Error 0.09	score on a scale

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	163
Overall Study	STARTED	Cariprazine 1.5 mg	160
Overall Study	STARTED	Cariprazine 3.0 mg	165
Overall Study	Received Treatment (Safety Population)	Placebo	158
Overall Study	Received Treatment (Safety Population)	Cariprazine 1.5 mg	157
Overall Study	Received Treatment (Safety Population)	Cariprazine 3.0 mg	165
Overall Study	COMPLETED	Placebo	135
Overall Study	COMPLETED	Cariprazine 1.5 mg	134
Overall Study	COMPLETED	Cariprazine 3.0 mg	134
Overall Study	NOT COMPLETED	Placebo	28

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events45

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	Nausea	Gastrointestinal disorders	Placebo	1	158
other	Nausea	Gastrointestinal disorders	Cariprazine 1.5 mg	6	157
other	Nausea	Gastrointestinal disorders	Cariprazine 3.0 mg	15	165
other	Dry mouth	Gastrointestinal disorders	Placebo	9	158
other	Dry mouth	Gastrointestinal disorders	Cariprazine 1.5 mg	6	157
other	Dry mouth	Gastrointestinal disorders	Cariprazine 3.0 mg	3	165
other	Headache	Nervous system disorders	Placebo	13	158
other	Headache	Nervous system disorders	Cariprazine 1.5 mg	7	157
other	Headache	Nervous system disorders	Cariprazine 3.0 mg	12	165
other	Akathisia	Nervous system disorders	Placebo	5	158

1 to 10 of 45Source ClinicalTrials.gov

See all 45 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	158
Total, all-cause mortality	Cariprazine 1.5 mg	0	157
Total, all-cause mortality	Cariprazine 3.0 mg	0	165
Total, other adverse events	Placebo	43	158
Total, other adverse events	Cariprazine 1.5 mg	48	157
Total, other adverse events	Cariprazine 3.0 mg	62	165
Total, serious adverse events	Placebo	2	158
Total, serious adverse events	Cariprazine 1.5 mg	2	157
Total, serious adverse events	Cariprazine 3.0 mg	2	165

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30845817	DERIVED	PubMed
31969269	DERIVED	PubMed
32942346	DERIVED	PubMed
33677183	DERIVED	PubMed
33915374	DERIVED	PubMed
37551609	DERIVED	PubMed
39520655	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/NCT02670551

GET https://conductscience.org/api/trials/v1/NCT02670551/events?page=2

API reference For AI assistants