Depression Clinical Trial
Official title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Fixed-Dose Clinical Trial Evaluating The Efficacy, Safety And Tolerability Of Cariprazine In Patients With Bipolar I Depression
Verified date | February 2019 |
Source | Forest Laboratories |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Forest Laboratories |
United States, Bulgaria, Croatia, Puerto Rico, Romania, Serbia, Slovakia, Ukraine,
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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