Trial · NCT01058668
Safety and Efficacy of Cariprazine for Bipolar I Disorder
NCT01058668, Phase 3, Completed, Forest Laboratories; results first posted 2017-04-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Cariprazine for Bipolar I Disorder. Trials, record NCT01058668. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01058668
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Cariprazine for Bipolar I Disorder
- NCT number
- NCT01058668
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 497 participants, actual
- Lead sponsor
- Forest Laboratories
- Conditions
- Mania, Bipolar I Disorder
- Interventions
- Cariprazine, Placebo
- First posted
- 2010-01-29
- Last updated
- 2017-04-12
- Results first posted
- 2017-04-12
- Limitations and caveats
- All participants from 1 investigative site were excluded due to Good Clinical Practice (GCP) Violations.
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 Young Mania Rating Scale (YMRS) Total Score at Week 3 | Baseline, Week 3 | The YMRS is an 11-item scale that assesses manic symptoms based on the participant's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a five-point scale (0-4) and 4-items on a nine-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis is a mixed model for repeated measurements (MMRM) using observed cases, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix. |
| Secondary | Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3 | Baseline, Week 3 | The CGI-S measures the investigator's assessment of overall severity of the participant's illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7= Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analysis is based on a MMRM using the observed cases data, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix. |
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 Young Mania Rating Scale (YMRS) Total Score at Week 3 | Baseline, Week 3 | Intent-to-treat Population included all participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3 | Baseline, Week 3 | Intent-to-treat Population included all participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment. | 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 the Young Mania Rating Scale (YMRS) Total Score at Week 3 | Placebo | -12.5 | Standard Error 0.8 | score on a scale | |
| Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3 | Cariprazine (3-6 mg/Day) | -18.6 | Standard Error 0.8 | score on a scale | |
| Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3 | Cariprazine (6-12 mg/Day) | -18.5 | Standard Error 0.8 | score on a scale | |
| Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3 | Placebo | -1.3 | Standard Error 0.1 | score on a scale | |
| Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3 | Cariprazine (3-6 mg/Day) | -1.9 | Standard Error 0.1 | score on a scale | |
| Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3 | Cariprazine (6-12 mg/Day) | -1.9 | Standard Error 0.1 | score on a scale |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Treatment Phase | STARTED | Placebo | 161 | |
| Double-blind Treatment Phase | STARTED | Cariprazine (3-6 mg/Day) | 167 | |
| Double-blind Treatment Phase | STARTED | Cariprazine (6-12 mg/Day) | 169 | |
| Double-blind Treatment Phase | COMPLETED | Placebo | 122 | |
| Double-blind Treatment Phase | COMPLETED | Cariprazine (3-6 mg/Day) | 129 | |
| Double-blind Treatment Phase | COMPLETED | Cariprazine (6-12 mg/Day) | 119 | |
| Double-blind Treatment Phase | NOT COMPLETED | Placebo | 39 | |
| Double-blind Treatment Phase | NOT COMPLETED | Cariprazine (3-6 mg/Day) | 38 | |
| Double-blind Treatment Phase | NOT COMPLETED | Cariprazine (6-12 mg/Day) | 50 | |
| Safety Follow-up | STARTED | Placebo | 144 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse 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 | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Placebo | 9 | 161 | |
| other | Nausea | Gastrointestinal disorders | Cariprazine (3-6 mg/Day) | 16 | 167 | |
| other | Nausea | Gastrointestinal disorders | Cariprazine (6-12 mg/Day) | 19 | 169 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 5 | 161 | |
| other | Constipation | Gastrointestinal disorders | Cariprazine (3-6 mg/Day) | 8 | 167 | |
| other | Constipation | Gastrointestinal disorders | Cariprazine (6-12 mg/Day) | 18 | 169 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 10 | 161 | |
| other | Vomiting | Gastrointestinal disorders | Cariprazine (3-6 mg/Day) | 15 | 167 | |
| other | Vomiting | Gastrointestinal disorders | Cariprazine (6-12 mg/Day) | 14 | 169 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 5 | 161 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Cariprazine (3-6 mg/Day) | ||
| Total, all-cause mortality | Cariprazine (6-12 mg/Day) | ||
| Total, other adverse events | Placebo | 63 | 161 |
| Total, other adverse events | Cariprazine (3-6 mg/Day) | 89 | 167 |
| Total, other adverse events | Cariprazine (6-12 mg/Day) | 90 | 169 |
| Total, serious adverse events | Placebo | 5 | 161 |
| Total, serious adverse events | Cariprazine (3-6 mg/Day) | 9 | 167 |
| Total, serious adverse events | Cariprazine (6-12 mg/Day) | 5 | 169 |
Source ClinicalTrials.gov
Papers3
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/NCT01058668
GET https://conductscience.org/api/trials/v1/NCT01058668/events?page=2