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
- Registration Number
- NCT02670538
- Lead Sponsor
- Forest Laboratories
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 493
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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
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Currently treated as an outpatient at the time of enrollment
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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
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HAMD-17 item 1 score ≥ 2
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CGI-S score ≥ 4
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Negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test (women of childbearing potential only)
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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)
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Young Mania Rating Scale (YMRS) total score > 12
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Four or more episodes of a mood disturbance (depression, mania, hypomania, or mixed state) within the 12 months before Visit 1
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Any current axis 1 psychiatric diagnosis other than bipolar disorder with the exception of specific phobias
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History of meeting DSM-5 criteria for:
- Dementia, amnesic, or other cognitive disorder
- Schizophrenia, schizoaffective, or other psychotic disorder
- Mental retardation
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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
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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
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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.
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Electroconvulsive therapy in the 3 months before Visit 1
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Previous lack of response to electroconvulsive therapy
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Treatment with a depot antipsychotic drug within 1 treatment cycle before Visit 1
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Treatment with clozapine in a dose of > 50 mg/day in the past 2 years
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Prior participation in any investigational study of RGH-188 or cariprazine within the past 12 months
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Previous treatment with vagus nerve stimulation or transcranial magnetic stimulation within 6 months before Visit 1
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Prior participation with any clinical trials, involving experimental or investigational drugs, within 6 months before Visit 1 or during the study
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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.
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Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
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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)
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Known history of cataracts or retinal detachment
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Known human immunodeficiency virus infection
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Employee, or immediate relative of an employee, of the Sponsor, any of its affiliates or partners, or the study center
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Following a 7 to 14 days screening/washout period, matching placebo capsule, one per day, orally for 6 weeks. Cariprazine 1.5 mg Cariprazine Following a 7 to 14 days screening/washout period, cariprazine 1.5 mg capsule, one per day, orally for 6 weeks. Cariprazine 3.0 mg Cariprazine Following a 7 to 14 days screening/washout period, cariprazine 1.5 milligrams (mg) capsule, one per day, orally for 2 weeks increased to cariprazine 3.0 mg capsule, one per day orally beginning on Day 15 for 4 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Baseline (Week 0) to Week 6 MADRS is a 10-item, clinician-rated scale that evaluates the participants 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 maximum severity for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Mixed-effects Model for Repeated Measures (MMRM) with fixed factors (treatment group, pooled study center, and visit), baseline (a covariate), and interactions (treatment group by visit, baseline by visit).
- Secondary Outcome Measures
Name Time Method Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score Baseline (Week 0) to Week 6 CGI-S is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of other patients the physician has observed. The participant was rated on a scale from 1 to 7, with 1 indicating a "normal state" and 7 indicating "among the most extremely ill patients". A negative change from Baseline indicates improvement. MMRM with fixed factors (treatment group, pooled study center, and visit), baseline (a covariate), and interactions (treatment group by visit, baseline by visit).
Trial Locations
- Locations (88)
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Mental Health Centre 'Prof. Dr. Ivan Temkov', EOOD
🇧🇬Burgas, Bulgaria
Polyclinic Neuron
🇭🇷Zagreb, Croatia
Clinical Center Nis Site 150
🇷🇸Nis, Serbia
Centrum zdravia R.B.K. s.r.o.
🇸🇰Bardejov, Slovakia
CI O.I. Yushchenko Vinnytsia Reg. Psychoneurological Hospital
🇺🇦Vinnytsia, Ukraine
CI Kherson Reg. Psychiatric Hospital of Kherson RC
🇺🇦Kherson, Ukraine
Transcarpathian Regional Narcological Dispensary
🇺🇦Uzhgorod, Ukraine
Alexian Brothers Center for Psychiatric Research
🇺🇸Hoffman Estates, Illinois, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Harmonex Neuroscience Research, Inc.
🇺🇸Dothan, Alabama, United States
CNS Clinical Research Group
🇺🇸Coral Springs, Florida, United States
Baber Research Group
🇺🇸Naperville, Illinois, United States
Collaborative Neuroscience Network, LLC
🇺🇸Torrance, California, United States
Millennium Psychiatric Associates
🇺🇸Creve Coeur, Missouri, United States
Barbara Diaz-Hernandez MD Research, Inc.
🇵🇷San Juan, Puerto Rico
Coastal Research Associates, Inc.
🇺🇸Weymouth, Massachusetts, United States
Professional Psychiatric Services
🇺🇸Mason, Ohio, United States
Center for Emotional Fitness
🇺🇸Cherry Hill, New Jersey, United States
UMHAT 'Dr. Georgi Stranski', Dept. of Psychiatry
🇧🇬Pleven, Bulgaria
Institutul de Psihiatrie Socola Iasi Site 111
🇷🇴Iasi, Romania
Innovative Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
Clinical Center of Serbia
🇷🇸Belgrade, Serbia
Cutting Edge Research Group
🇺🇸Oklahoma City, Oklahoma, United States
SPRI Clinical Trials, LLC
🇺🇸Brooklyn, New York, United States
Grayline Research Center
🇺🇸Wichita Falls, Texas, United States
Eastside Comprehensive Medical Center
🇺🇸New York, New York, United States
UMHAT "Sv. Georgi", EAD
🇧🇬Plovdiv, Bulgaria
Brooklyn Medical Institute
🇺🇸Brooklyn, New York, United States
Pharmaceutical Research Associates, Inc.
🇺🇸Marlton, New Jersey, United States
Tulsa Clinical Research, LLC
🇺🇸Tulsa, Oklahoma, United States
Psychiatric Hospital "Sveti Ivan"
🇭🇷Zagreb, Croatia
Regional Psychoneurological Hospital #3, Dept of Primary Psych Episode
🇺🇦Ivano-Frankivsk, Ukraine
DCC "Mladost M" - Varna, OOD Site 188
🇧🇬Varna, Bulgaria
CI of Kyiv Reg.Council Reg.Psychiatric-Narcological Medical Association
🇺🇦Glevakha, Ukraine
Regional Psychoneurological Hospital #3
🇺🇦Ivano-Frankivsk, Ukraine
CI Odesa Regional Medical Center of Mental Health
🇺🇦Odesa, Ukraine
CI Odesa Regional Psychiatric Hospital # 2
🇺🇦Komintern, Ukraine
SI Inst.of Neurology, Psychiatry and Narcology of NAMS of Ukraine
🇺🇦Kharkiv, Ukraine
Innova Clinical Trials, Inc.
🇺🇸Miami, Florida, United States
Houston Endoscopy and Research Center
🇺🇸Houston, Texas, United States
Capstone Clinical Research
🇺🇸Libertyville, Illinois, United States
DCC "Mladost M" - Varna, OOD Site 194
🇧🇬Varna, Bulgaria
Advanced Research Center, Inc
🇺🇸Anaheim, California, United States
Woodland International Research Group, LLC
🇺🇸Little Rock, Arkansas, United States
NoesisPharma, LLC
🇺🇸Phoenix, Arizona, United States
Behavioral Research Specialists, LLC
🇺🇸Glendale, California, United States
Excell Research, Inc.
🇺🇸Oceanside, California, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Comprehensive Clinical Research
🇺🇸Washington, District of Columbia, United States
Research Centers of America, LLC
🇺🇸Oakland Park, Florida, United States
J. Gary Booker, MD, APMC
🇺🇸Shreveport, Louisiana, United States
St. Louis Clinical Trials, LLC
🇺🇸Saint Louis, Missouri, United States
Manhattan Behavioral Medicine
🇺🇸New York, New York, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Clinical Trials of America, Inc
🇺🇸Hickory, North Carolina, United States
University at Buffalo Erie County Medical Center
🇺🇸Buffalo, New York, United States
University of Cincinnati - Department of Psychiatry and Behavioral Neuroscience
🇺🇸Cincinnati, Ohio, United States
Carolina Clinical Trials, Inc.
🇺🇸Charleston, South Carolina, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
Pacific Institute of Medical Sciences
🇺🇸Bothell, Washington, United States
Clinical Centre Kragujevac Site 158
🇷🇸Kragujevac, Serbia
Clinical Center Zvezdara
🇷🇸Belgrade, Serbia
Institute of Mental Health
🇷🇸Belgrade, Serbia
CI of LRC Lviv Reg. Council Lviv Reg.Clinical Psychoneurological Dispensary
🇺🇦Lviv, Ukraine
Neuropsychiatric Hospital Ivan Barbot
🇭🇷Popovača, Croatia
Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila"
🇷🇴Bucuresti, Romania
Spitalul de Psihiatrie Titan "Dr. Constantin Gorgos"
🇷🇴Bucuresti, Romania
General Hospital Euromedic
🇷🇸Belgrade, Serbia
Clinical Center Nis Site 160
🇷🇸Nis, Serbia
University Hospital Center Zagreb
🇭🇷Zagreb, Croatia
Clinical Center "Dr. Dragisa Misovic"
🇷🇸Belgrade, Serbia
Liptovska nemocnica s poliklinikou Liptovsky Mikulas
🇸🇰Liptovsky Mikulas, Slovakia
Nemocnica s poliklinikou sv. Barbory, Roznava a.s.
🇸🇰Rožňava, Slovakia
Crystal Comfort s.r.o.
🇸🇰Vranov nad Toplou, Slovakia
MHAT "Dr. Hristo Stambolski", EOOD
🇧🇬Kazanlak, Bulgaria
Clinical Hospital Center Rijeka
🇭🇷Rijeka, Croatia
Spitalul de Psihiatrie "Elisabeta Doamna" Galati
🇷🇴Galati, Romania
Clinic for Psychiatry Vrapce
🇭🇷Zagreb, Croatia
Institutul de Psihiatrie Socola Iasi Site 113
🇷🇴Iasi, Romania
Clinic of Psychiatric Diseases "Dr Laza Lazarevic"
🇷🇸Belgrade, Serbia
Clinical Center Kragujevac Site 154
🇷🇸Kragujevac, Serbia
Specialized Hospital for Neuropsychiatric Diseases "Sveti Vracevi"
🇷🇸Novi Knezevac, Serbia
Vavrusova Consulting s.r.o.
🇸🇰Bratislava, Slovakia
PsychoLine s.r.o.
🇸🇰Rimavská Sobota, Slovakia
CI Cherkasy Regional Psychiatric Hospital of ChRC
🇺🇦Smila, Ukraine
Ternopil Reg. Communal Clinical Psychoneurological Hospital Depts of Psychiatry #2
🇺🇦Ternopil, Ukraine
Radiant Research
🇺🇸Cerritos, California, United States