Trial · NCT02670538
Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder
NCT02670538, Phase 3, Completed, Forest Laboratories; results first posted 2019-02-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder. Trials, record NCT02670538. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02670538
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder
- NCT number
- NCT02670538
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 493 participants, actual
- Lead sponsor
- Forest Laboratories
- Conditions
- Bipolar Disorder, Depression
- Interventions
- Cariprazine, Placebo
- First posted
- 2016-02-01
- Last updated
- 2019-03-12
- Other registries' IDs
- eudract:2016-000756-98
- Results first posted
- 2019-02-05
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 Montgomery-Åsberg Depression Rating Scale (MADRS) | Baseline (Week 0) to Week 6 | MADRS is a 10-item, clinician-rated scale that evaluates the participants 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. Mixed-effects Model for Repeated Measures (MMRM) with fixed factors (treatment group, pooled study center, and visit), baseline (a covariate), and interactions (treatment group by visit, baseline by visit). |
| Secondary | Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score | Baseline (Week 0) to Week 6 | CGI-S is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of other patients 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 patients". A negative change from Baseline indicates improvement. MMRM with fixed factors (treatment group, pooled study center, and visit), baseline (a covariate), and interactions (treatment group by visit, baseline by visit). |
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 Montgomery-Åsberg Depression Rating Scale (MADRS) | Baseline (Week 0) to Week 6 | ITT Population consisted of all participants in Safety Population who had at least 1 postbaseline assessment of MADRS total score. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score | Baseline (Week 0) to Week 6 | ITT population consisted of all participants in Safety Population who had at least 1 postbaseline assessment of MADRS total score. | 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 | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) | Placebo | -12.4 | Standard Error 0.75 | score on a scale | |
| Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) | Cariprazine 1.5 mg | -14.8 | Standard Error 0.76 | score on a scale | |
| Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) | Cariprazine 3.0 mg | -14.1 | Standard Error 0.78 | score on a scale | |
| Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score | Placebo | -1.2 | Standard Error 0.09 | score on a scale | |
| Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score | Cariprazine 1.5 mg | -1.5 | Standard Error 0.09 | score on a scale | |
| Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score | Cariprazine 3.0 mg | -1.4 | Standard Error 0.09 | score on a scale |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 167 | |
| Overall Study | STARTED | Cariprazine 1.5 mg | 168 | |
| Overall Study | STARTED | Cariprazine 3.0 mg | 158 | |
| Overall Study | Safety Population : Received Study Drug | Placebo | 165 | |
| Overall Study | Safety Population : Received Study Drug | Cariprazine 1.5 mg | 167 | |
| Overall Study | Safety Population : Received Study Drug | Cariprazine 3.0 mg | 158 | |
| Overall Study | Intent-to-Treat Population | Placebo | 163 | |
| Overall Study | Intent-to-Treat Population | Cariprazine 1.5 mg | 162 | |
| Overall Study | Intent-to-Treat Population | Cariprazine 3.0 mg | 153 | |
| Overall Study | COMPLETED | Placebo | 135 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events42
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 | Nausea | Gastrointestinal disorders | Placebo | 5 | 165 | |
| other | Nausea | Gastrointestinal disorders | Cariprazine 1.5 mg | 13 | 167 | |
| other | Nausea | Gastrointestinal disorders | Cariprazine 3.0 mg | 8 | 158 | |
| other | Fatigue | General disorders | Placebo | 2 | 165 | |
| other | Fatigue | General disorders | Cariprazine 1.5 mg | 9 | 167 | |
| other | Fatigue | General disorders | Cariprazine 3.0 mg | 5 | 158 | |
| other | Akathisia | Nervous system disorders | Placebo | 3 | 165 | |
| other | Akathisia | Nervous system disorders | Cariprazine 1.5 mg | 9 | 167 | |
| other | Akathisia | Nervous system disorders | Cariprazine 3.0 mg | 15 | 158 | |
| other | Headache | Nervous system disorders | Placebo | 14 | 165 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 165 |
| Total, all-cause mortality | Cariprazine 1.5 mg | 0 | 167 |
| Total, all-cause mortality | Cariprazine 3.0 mg | 0 | 158 |
| Total, other adverse events | Placebo | 36 | 165 |
| Total, other adverse events | Cariprazine 1.5 mg | 45 | 167 |
| Total, other adverse events | Cariprazine 3.0 mg | 45 | 158 |
| Total, serious adverse events | Placebo | 5 | 165 |
| Total, serious adverse events | Cariprazine 1.5 mg | 1 | 167 |
| Total, serious adverse events | Cariprazine 3.0 mg | 1 | 158 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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.
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/NCT02670538
GET https://conductscience.org/api/trials/v1/NCT02670538/events?page=2