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

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar Disorder, Depression

In brief

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.

Key facts

Study ID

NCT02670538

Run by

Forest Laboratories

People needed

493

Starts

2016-03-31

Expected to finish

2018-01-18

Last updated by the study team

2019-03-12

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
• Patient 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
• 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:
• Patients with a positive cannabinoid on entry may be retested before randomization. If the patient remains positive, the patient is no longer eligible
• Patients 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

• Harmonex Neuroscience Research, Inc. — Dothan, Alabama, United States
• NoesisPharma, LLC — Phoenix, Arizona, United States
• Woodland International Research Group, LLC — Little Rock, Arkansas, United States
• Advanced Research Center, Inc — Anaheim, California, United States
• Radiant Research — Cerritos, California, United States
• Collaborative Neuroscience Network, LLC — Garden Grove, California, United States
• Behavioral Research Specialists, LLC — Glendale, California, United States
• Excell Research, Inc. — Oceanside, California, United States
• Collaborative Neuroscience Network, LLC — Torrance, California, United States
• Comprehensive Clinical Research — Washington D.C., District of Columbia, United States
• CNS Clinical Research Group — Coral Springs, Florida, United States
• MD Clinical — Hallandale, Florida, United States
• Innovative Clinical Research, Inc. — Lauderhill, Florida, United States
• Innova Clinical Trials, Inc. — Miami, Florida, United States
• Research Centers of America, LLC — Oakland Park, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Alexian Brothers Center for Psychiatric Research — Hoffman Estates, Illinois, United States
• Capstone Clinical Research — Libertyville, Illinois, United States
• Baber Research Group — Naperville, Illinois, United States
• J. Gary Booker, MD, APMC — Shreveport, Louisiana, United States
• Coastal Research Associates, Inc. — Weymouth, Massachusetts, United States
• Millennium Psychiatric Associates — Creve Coeur, Missouri, United States
• St. Louis Clinical Trials, LLC — St Louis, Missouri, United States
• Center for Emotional Fitness — Cherry Hill, New Jersey, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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