Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02670551 · ClinicalTrials.gov registry record · Phase 3
Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression
A Phase 3 study of Depression and Bipolar Disorder, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 488
- Enrollment target
- 20
- Study locations
NCT02670551: Completed Phase 3 study of Depression and Bipolar Disorder, sponsored by Forest Laboratories.
NCT02670551 is a Phase 3 study of Depression and Bipolar Disorder that has completed, run by Forest Laboratories. The registered enrollment target is 488 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (38% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02670551, a Phase 3 study of Depression and Bipolar Disorder, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 488 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 milligram (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
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item, clinician-rated scale that evaluates the participant's 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 maxim
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cariprazine
Study Locations (20)
California
- ATP Clinical Research, Inc. - Costa Mesa
- Synergy San Diego - Escondido
- Integrated Medical and Behavioral Associates - Glendale
- Apostle Clinical Trials, Inc. - Long Beach
- Pacific Research Partners, LLC - Oakland
- Artemis Institute for Clinical Research - San Diego
- Schuster Medical Research Institute - Sherman Oaks
- Viking Clinical Research - Temecula
- Pacific Clinical Research Medical Group - Upland
Georgia
- Radiant Research - Atlanta
- iResearch Atlanta, LLC - Decatur
- Northwest Behavioral Research Center - Marietta
- Carman Research - Smyrna
Florida
- CNS Healthcare - Jacksonville
- Clinical Neuroscience Solutions, Inc - Orlando
- Olympian Clinical Research - Tampa
Illinois
- Psychiatric Medicine Associates, L.L.C - Skokie
- Neuroscience Research Institute Inc. - Winfield
Arkansas
- Arkansas Psychiatric Clinic Clinical Research Trials PA - Little Rock
Connecticut
- Comprehensive Psychiatric Care - Norwich
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 488 participants |
| Start Date | 2016-03-17 |
| Est. Completion | 2017-07-19 |
| Phase | Phase 3 |
What the finished NCT02670551 record still lists
NCT02670551 is an interventional study that assigns participants to a tested intervention. The registered 488 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (38% lower).
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02670551 names 20 study sites across 6 states, led by California, Georgia, Florida.
Frequently Asked Questions
What is clinical trial NCT02670551 about?
NCT02670551 is a clinical study titled "Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression". This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 milligram (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.
What is the current status of trial NCT02670551?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 488 participants. The study started on 2016-03-17. Estimated completion is 2017-07-19.
What conditions does trial NCT02670551 study?
This clinical trial studies the following conditions: Depression, Bipolar Disorder.
What interventions are being tested in trial NCT02670551?
The interventions under investigation include: Placebo (DRUG), Cariprazine (DRUG).
Who is sponsoring clinical trial NCT02670551?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02670551 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02670551's enrollment target sits among peer trials
488 90th of 679 higher than 590 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression 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
-
Behavioral Activation Delivered Via Home-based Telehealth to Improve Functioning in Cardiovascular Disease Patients Recently Discharged From Inpatient Care
RECRUITING · Phase 3
-
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
RECRUITING · Phase 3
-
A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.
RECRUITING · Phase 3
-
PCORI Comparative Effectiveness Study-Esketamine (Spravato) vs. Ketamine-Equivalence Study
RECRUITING · Phase 3
-
Creatine for Depressed Male and Female Methamphetamine Users
RECRUITING · Phase 3
-
E-Mindfulness Approaches for Living After Breast Cancer
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05154669 · 488 participants · Phase 3
Integrating Financial Coaching and Smoking Cessation Coaching
- NCT06532877 · 488 participants · NA
Telephone Support in Advanced Gastrointestinal Cancer
- NCT06602479 · 488 participants · Phase 2
A Study to Investigate the Safety and Efficacy of MEDI0618 Compared to Placebo in Adult Participants With Episodic Migraine
- NCT06794983 · 488 participants · NA
Calls and Coordination for Transitions of Care at Re-entry
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT06358040 · started 2026-10 · NA
Opioid Dispenser for Microdiscectomy/Laminectomy