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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02670538
Other study ID # RGH-MD-53
Secondary ID 2016-000756-98
Status Completed
Phase Phase 3
First received
Last updated
Start date March 31, 2016
Est. completion date January 18, 2018

Study information

Verified date February 2019
Source Forest Laboratories
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 493
Est. completion date January 18, 2018
Est. primary completion date January 18, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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 ß-human chorionic gonadotropin (ß-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)

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cariprazine
Cariprazine capsule one per day orally.
Placebo
Matching placebo capsule one per day orally.

Locations

Country Name City State
Bulgaria Mental Health Centre 'Prof. Dr. Ivan Temkov', EOOD Burgas
Bulgaria MHAT "Dr. Hristo Stambolski", EOOD Kazanlak
Bulgaria UMHAT 'Dr. Georgi Stranski', Dept. of Psychiatry Pleven
Bulgaria UMHAT "Sv. Georgi", EAD Plovdiv
Bulgaria DCC "Mladost M" - Varna, OOD Site 188 Varna
Bulgaria DCC "Mladost M" - Varna, OOD Site 194 Varna
Croatia Neuropsychiatric Hospital Ivan Barbot Popovaca
Croatia Clinical Hospital Center Rijeka Rijeka
Croatia Clinic for Psychiatry Vrapce Zagreb
Croatia Polyclinic Neuron Zagreb
Croatia Psychiatric Hospital "Sveti Ivan" Zagreb
Croatia University Hospital Center Zagreb Zagreb
Puerto Rico Barbara Diaz-Hernandez MD Research, Inc. San Juan
Romania Spitalul de Psihiatrie Titan "Dr. Constantin Gorgos" Bucuresti
Romania Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila" Bucuresti
Romania Spitalul de Psihiatrie "Elisabeta Doamna" Galati Galati
Romania Institutul de Psihiatrie Socola Iasi Site 111 Iasi
Romania Institutul de Psihiatrie Socola Iasi Site 113 Iasi
Serbia Clinic of Psychiatric Diseases "Dr Laza Lazarevic" Belgrade
Serbia Clinical Center "Dr. Dragisa Misovic" Belgrade
Serbia Clinical Center of Serbia Belgrade
Serbia Clinical Center Zvezdara Belgrade
Serbia General Hospital Euromedic Belgrade
Serbia Institute of Mental Health Belgrade
Serbia Clinical Center Kragujevac Site 154 Kragujevac
Serbia Clinical Centre Kragujevac Site 158 Kragujevac
Serbia Clinical Center Nis Site 150 Nis
Serbia Clinical Center Nis Site 160 Nis
Serbia Specialized Hospital for Neuropsychiatric Diseases "Sveti Vracevi" Novi Knezevac
Slovakia Centrum zdravia R.B.K. s.r.o. Bardejov
Slovakia Vavrusova Consulting s.r.o. Bratislava
Slovakia Liptovska nemocnica s poliklinikou Liptovsky Mikulas Liptovsky Mikulas
Slovakia PsychoLine s.r.o. Rimavská Sobota
Slovakia Nemocnica s poliklinikou sv. Barbory, Roznava a.s. Rožnava
Slovakia Crystal Comfort s.r.o. Vranov nad Toplou
Ukraine CI of Kyiv Reg.Council Reg.Psychiatric-Narcological Medical Association Glevakha
Ukraine Regional Psychoneurological Hospital #3 Ivano-Frankivsk
Ukraine Regional Psychoneurological Hospital #3, Dept of Primary Psych Episode Ivano-Frankivsk
Ukraine SI Inst.of Neurology, Psychiatry and Narcology of NAMS of Ukraine Kharkiv
Ukraine CI Kherson Reg. Psychiatric Hospital of Kherson RC Kherson
Ukraine CI Odesa Regional Psychiatric Hospital # 2 Komintern
Ukraine CI of LRC Lviv Reg. Council Lviv Reg.Clinical Psychoneurological Dispensary Lviv
Ukraine CI Odesa Regional Medical Center of Mental Health Odesa
Ukraine CI Cherkasy Regional Psychiatric Hospital of ChRC Smila
Ukraine Ternopil Reg. Communal Clinical Psychoneurological Hospital Depts of Psychiatry #2 Ternopil
Ukraine Transcarpathian Regional Narcological Dispensary Uzhgorod
Ukraine CI O.I. Yushchenko Vinnytsia Reg. Psychoneurological Hospital Vinnytsia
United States Advanced Research Center, Inc Anaheim California
United States Atlanta Center for Medical Research Atlanta Georgia
United States University of Alabama at Birmingham Birmingham Alabama
United States Pacific Institute of Medical Sciences Bothell Washington
United States Brooklyn Medical Institute Brooklyn New York
United States SPRI Clinical Trials, LLC Brooklyn New York
United States University at Buffalo Erie County Medical Center Buffalo New York
United States Radiant Research Cerritos California
United States Carolina Clinical Trials, Inc. Charleston South Carolina
United States Center for Emotional Fitness Cherry Hill New Jersey
United States University of Cincinnati - Department of Psychiatry and Behavioral Neuroscience Cincinnati Ohio
United States CNS Clinical Research Group Coral Springs Florida
United States Millennium Psychiatric Associates Creve Coeur Missouri
United States Harmonex Neuroscience Research, Inc. Dothan Alabama
United States Collaborative Neuroscience Network, LLC Garden Grove California
United States Behavioral Research Specialists, LLC Glendale California
United States MD Clinical Hallandale Beach Florida
United States Clinical Trials of America, Inc Hickory North Carolina
United States Alexian Brothers Center for Psychiatric Research Hoffman Estates Illinois
United States Houston Endoscopy and Research Center Houston Texas
United States Innovative Clinical Research, Inc. Lauderhill Florida
United States Capstone Clinical Research Libertyville Illinois
United States Woodland International Research Group, LLC Little Rock Arkansas
United States Pharmaceutical Research Associates, Inc. Marlton New Jersey
United States Professional Psychiatric Services Mason Ohio
United States Suburban Research Associates Media Pennsylvania
United States Innova Clinical Trials, Inc. Miami Florida
United States Baber Research Group Naperville Illinois
United States Eastside Comprehensive Medical Center New York New York
United States Manhattan Behavioral Medicine New York New York
United States Research Centers of America, LLC Oakland Park Florida
United States Excell Research, Inc. Oceanside California
United States Cutting Edge Research Group Oklahoma City Oklahoma
United States NoesisPharma, LLC Phoenix Arizona
United States Finger Lakes Clinical Research Rochester New York
United States St. Louis Clinical Trials, LLC Saint Louis Missouri
United States J. Gary Booker, MD, APMC Shreveport Louisiana
United States Collaborative Neuroscience Network, LLC Torrance California
United States Tulsa Clinical Research, LLC Tulsa Oklahoma
United States Comprehensive Clinical Research Washington District of Columbia
United States Coastal Research Associates, Inc. Weymouth Massachusetts
United States Grayline Research Center Wichita Falls Texas

Sponsors (1)

Lead Sponsor Collaborator
Forest Laboratories

Countries where clinical trial is conducted

United States,  Bulgaria,  Croatia,  Puerto Rico,  Romania,  Serbia,  Slovakia,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) 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). Baseline (Week 0) to Week 6
Secondary Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score 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). Baseline (Week 0) to Week 6
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