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

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar Disorder, Depression

In brief

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.

Key facts

Study ID

NCT02670551

Run by

Forest Laboratories

People needed

488

Starts

2016-03-17

Expected to finish

2017-07-19

Last updated by the study team

2019-01-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder without psychotic features confirmed by the administration of the Mini International Neuropsychiatric Interview (MINI), with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration
• Currently treated as an outpatient at the time of enrollment
• A verified previous manic or mixed episode. Verification must include one of the following sources: --Treatment of mania with an anti-manic agent (eg, lithium or divalproate) or antipsychotic medication with an approved indication for mania --Hospital records/Medical records --Participant report corroborated by caretaker or previous or current treating clinician
• 17-item Hamilton Depression Rating Scale (HAMD-17) total score ≥ 20
• HAMD-17 item 1 score ≥ 2
• Clinical Global Impressions-Severity (CGI-S) score ≥ 4
• Negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test (women of childbearing potential only)
• Normal physical examination, clinical laboratory test results, and electrocardiogram (ECG) results or abnormal findings that are judged not clinically significant by the Principal Investigator (PI)

You may not qualify if…

• Young Mania Rating Scale (YMRS) total score > 12
• Four or more episodes of a mood disturbance (depression, mania, hypomania, or mixed state) within the 12 months before Visit 1
• Any current axis 1 psychiatric diagnosis other than bipolar disorder with the exception of specific phobias
• History of meeting DSM-5 criteria for: ○ Dementia, amnesic, or other cognitive disorder ○ Schizophrenia, schizoaffective, or other psychotic disorder
• ○ Mental retardation - DSM-5-based diagnosis of borderline or antisocial personality disorder or other axis II disorder of sufficient severity to interfere with participation in this study
• History of meeting DSM-5 criteria for alcohol or substance abuse or dependence (other than nicotine or caffeine) within the 6 months before Visit 1
• Positive result on blood alcohol test or urine drug screen for any prohibited medication. Exception: ○ Participants with a positive cannabinoid on entry may be retested before randomization. If the participant remains positive, the participant is no longer eligible ○ Participants positive for opiates on entry, discussion with Study Physician is required.
• Electroconvulsive therapy in the 3 months before Visit 1
• Previous lack of response to electroconvulsive therapy
• Treatment with a depot antipsychotic drug within 1 treatment cycle before Visit 1
• Treatment with clozapine in a dose of > 50 mg/day in the past 2 years
• Prior participation in any investigational study of RGH-188 or cariprazine within the past 12 months
• Previous treatment with vagus nerve stimulation or transcranial magnetic stimulation within 6 months before Visit 1
• Prior participation with any clinical trials, involving experimental or investigational drugs, within 6 months before Visit 1 or during the study
• Initiation or termination of psychotherapy for depression within the 3 months preceding Visit 1, or plans to initiate, terminate, or change such therapy during the course of the study.
• Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
• Gastric bypass or any condition that would be expected to affect drug absorption (lap band procedures are acceptable if there is no problem with absorption)
• Known history of cataracts or retinal detachment
• Known human immunodeficiency virus infection
• Employee, or immediate relative of an employee, of the Sponsor, any of its affiliates or partners, or the study center

Where it is running

• ATP Clinical Research, Inc. — Costa Mesa, California, United States
• Synergy San Diego — Escondido, California, United States
• Integrated Medical and Behavioral Associates — Glendale, California, United States
• Apostle Clinical Trials, Inc. — Long Beach, California, United States
• Pacific Research Partners, LLC — Oakland, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Schuster Medical Research Institute — Sherman Oaks, California, United States
• Viking Clinical Research — Temecula, California, United States
• Pacific Clinical Research Medical Group — Upland, California, United States
• Comprehensive Psychiatric Care — Norwich, Connecticut, United States
• CNS Healthcare — Jacksonville, Florida, United States
• Clinical Neuroscience Solutions, Inc — Orlando, Florida, United States
• Olympian Clinical Research — Tampa, Florida, United States
• Radiant Research — Atlanta, Georgia, United States
• iResearch Atlanta, LLC — Decatur, Georgia, United States
• Northwest Behavioral Research Center — Marietta, Georgia, United States
• Carman Research — Smyrna, Georgia, United States
• Psychiatric Medicine Associates, L.L.C — Skokie, Illinois, United States
• Neuroscience Research Institute Inc. — Winfield, Illinois, United States
• St. Charles Psychiatric Associates - Midwest Research Group — Saint Charles, Missouri, United States
• Altea Research Institute — Las Vegas, Nevada, United States
• Hassman Research Institute — Berlin, New Jersey, United States
• Neurobehavioral Research, Inc. — Cedarhurst, New York, United States
• Medical & Behavioral Health Research, PC — New York, New York, United States
• Arkansas Psychiatric Clinic Clinical Research Trials PA — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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