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NCT02670538 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 493
- Enrollment target
NCT02670538: Completed Phase 3 study, sponsored by Forest Laboratories.
NCT02670538 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 493 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
NCT02670538, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 493 participants
- Enrollment target
Study Summary
This study is designed to prospectively confirm the efficacy of a fixed-dose regimen of cariprazine 1.5 milligrams (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG Cariprazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 493 participants |
| Start Date | 2016-03-31 |
| Est. Completion | 2018-01-18 |
| Phase | Phase 3 |
What the finished NCT02670538 record still lists
NCT02670538 is an interventional study that assigns participants to a tested intervention. The registered 493 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.
NCT02670538 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02670538 about?
NCT02670538 is a clinical study titled "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". This study is designed to prospectively confirm the efficacy of a fixed-dose regimen of cariprazine 1.5 milligrams (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be ...
What is the current status of trial NCT02670538?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 493 participants. The study started on 2016-03-31. Estimated completion is 2018-01-18.
What interventions are being tested in trial NCT02670538?
The interventions under investigation include: Placebo (DRUG), Cariprazine (DRUG).
Who is sponsoring clinical trial NCT02670538?
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 NCT02670538's enrollment target sits among peer trials
493 779th of 2000 higher than 1,221 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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