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COMPLETED Phase 3

Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression

NCT02670551 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 488 participants
Start Date 2016-03-17
Est. Completion 2017-07-19
Phase Phase 3

Sponsor

Forest Laboratories

32 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02670551

The ClinicalTrials.gov registry entry for NCT02670551 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 488 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02670551 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Georgia, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02670551?

The interventions under investigation include: Placebo (DRUG), Cariprazine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02670551?

This trial is sponsored by Forest Laboratories, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial