Trial · NCT01396447
Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression
NCT01396447, Phase 2, Completed, Forest Laboratories; results first posted 2018-05-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression. Trials, record NCT01396447. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01396447
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression
- NCT number
- NCT01396447
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 584 participants, actual
- Lead sponsor
- Forest Laboratories
- Conditions
- Depression, Bipolar
- Interventions
- Placebo, Cariprazine
- First posted
- 2011-07-18
- Last updated
- 2018-05-01
- Other registries' IDs
- eudract:2011-002334-39
- Results first posted
- 2018-05-01
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 Total Score at Week 6 | Baseline to Week 6 | The Montgomery-Åsberg Depression Rating Scale is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The scores on the 10 items are summed for a total score that can range from 0 to 60. A higher score indicates greater depression. A negative change score indicates improvement. |
| Secondary | Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6 | Baseline to Week 6 | The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change score 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 Total Score at Week 6 | Baseline to Week 6 | Intent-to-treat population: All randomized participants who took at least 1 dose of investigational product and had at least 1 post-Baseline assessment of the Montgomery-Åsberg Depression Rating Scale. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6 | Baseline to Week 6 | Intent-to-treat population: All randomized participants who took at least 1 dose of investigational product and had at least 1 post-Baseline assessment of the Montgomery-Åsberg Depression Rating Scale. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group8
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 the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6 | Placebo | -11.1 | Standard Error 0.9 | units on a scale | |
| Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6 | Cariprazine 0.75 mg | -13.0 | Standard Error 0.9 | units on a scale | |
| Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6 | Cariprazine 1.5 mg | -15.1 | Standard Error 0.8 | units on a scale | |
| Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6 | Cariprazine 3.0 mg | -13.7 | Standard Error 0.9 | units on a scale | |
| Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6 | Placebo | -1.0 | Standard Error 0.1 | units on a scale | |
| Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6 | Cariprazine 0.75 mg | -1.1 | Standard Error 0.1 | units on a scale | |
| Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6 | Cariprazine 1.5 mg | -1.4 | Standard Error 0.1 | units on a scale | |
| Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6 | Cariprazine 3.0 mg | -1.3 | Standard Error 0.1 | units on a scale |
Source ClinicalTrials.gov
Participant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 148 | |
| Overall Study | STARTED | Cariprazine 0.75 mg | 143 | |
| Overall Study | STARTED | Cariprazine 1.5 mg | 147 | |
| Overall Study | STARTED | Cariprazine 3.0 mg | 146 | |
| Overall Study | Received Treatment | Placebo | 145 | |
| Overall Study | Received Treatment | Cariprazine 0.75 mg | 141 | |
| Overall Study | Received Treatment | Cariprazine 1.5 mg | 146 | |
| Overall Study | Received Treatment | Cariprazine 3.0 mg | 146 | |
| Overall Study | COMPLETED | Placebo | 105 | |
| Overall Study | COMPLETED | Cariprazine 0.75 mg | 103 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events68
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 | 7 | 145 | |
| other | Nausea | Gastrointestinal disorders | Cariprazine 0.75 mg | 12 | 141 | |
| other | Nausea | Gastrointestinal disorders | Cariprazine 1.5 mg | 12 | 146 | |
| other | Nausea | Gastrointestinal disorders | Cariprazine 3.0 mg | 12 | 146 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 10 | 145 | |
| other | Diarrhoea | Gastrointestinal disorders | Cariprazine 0.75 mg | 2 | 141 | |
| other | Diarrhoea | Gastrointestinal disorders | Cariprazine 1.5 mg | 9 | 146 | |
| other | Diarrhoea | Gastrointestinal disorders | Cariprazine 3.0 mg | 3 | 146 | |
| other | Akathisia | Nervous system disorders | Placebo | 2 | 145 | |
| other | Akathisia | Nervous system disorders | Cariprazine 0.75 mg | 4 | 141 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 145 |
| Total, all-cause mortality | Cariprazine 0.75 mg | 0 | 141 |
| Total, all-cause mortality | Cariprazine 1.5 mg | 0 | 146 |
| Total, all-cause mortality | Cariprazine 3.0 mg | 0 | 146 |
| Total, other adverse events | Placebo | 42 | 145 |
| Total, other adverse events | Cariprazine 0.75 mg | 43 | 141 |
| Total, other adverse events | Cariprazine 1.5 mg | 51 | 146 |
| Total, other adverse events | Cariprazine 3.0 mg | 56 | 146 |
| Total, serious adverse events | Placebo | 5 | 145 |
| Total, serious adverse events | Cariprazine 0.75 mg | 1 | 141 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers7
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/NCT01396447
GET https://conductscience.org/api/trials/v1/NCT01396447/events?page=2