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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 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 493 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02670538
The ClinicalTrials.gov registry entry for NCT02670538 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 493 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02670538 reports 0 study locations.
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.
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