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NCT01058668 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Cariprazine for Bipolar I Disorder
A Phase 3 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 497
- Enrollment target
NCT01058668: Completed Phase 3 study, sponsored by Forest Laboratories.
NCT01058668 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 497 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01058668, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 497 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG Cariprazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 497 participants |
| Start Date | 2010-02 |
| Est. Completion | 2011-12 |
| Phase | Phase 3 |
What the finished NCT01058668 record still lists
NCT01058668 is an interventional study that assigns participants to a tested intervention. The registered 497 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01058668 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01058668 about?
NCT01058668 is a clinical study titled "Safety and Efficacy of Cariprazine for Bipolar I Disorder". The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.
What is the current status of trial NCT01058668?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 497 participants. The study started on 2010-02. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01058668?
The interventions under investigation include: Placebo (DRUG), Cariprazine (DRUG).
Who is sponsoring clinical trial NCT01058668?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01058668's enrollment target sits among peer trials
497 775th of 2000 higher than 1,225 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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