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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02670551
Recruitment Status : Completed
First Posted : February 1, 2016
Results First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Tracking Information
First Submitted Date  ICMJE January 28, 2016
First Posted Date  ICMJE February 1, 2016
Results First Submitted Date  ICMJE January 10, 2019
Results First Posted Date  ICMJE January 30, 2019
Last Update Posted Date January 30, 2019
Actual Study Start Date  ICMJE March 17, 2016
Actual Primary Completion Date July 19, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Week 6 [ Time Frame: Baseline (Week 0) to Week 6 ]
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item, clinician-rated scale that evaluates the participant's 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2016)
Change from Baseline Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Baseline (Week 0) to Week 6 ]
The Montgomery-Åsberg Depression Rating Scale is a 10-item, clinician-rated scale that evaluates the patient's depressive symptomatology during the past week. Patients are 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 will be scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 6 [ Time Frame: Baseline (Week 0) to Week 6 ]
The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of other participants 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 participants." A negative change from Baseline indicates improvement.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2016)
Change from baseline in Clinical Global Impressions-Severity (CGI-S) score [ Time Frame: Baseline (Week 0) to Week 6 ]
The Clinical Global Impressions-Severity is a clinician-rated scale that measures the overall severity of a patient's illness in comparison with the severity of other patients the physician has observed. The patient is rated on a scale from 1 to 7, with 1 indicating a "normal state" and 7 indicating "among the most extremely ill patients."
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorder
  • Depression
Intervention  ICMJE
  • Drug: Cariprazine
    Other Name: VRAYLAR®
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Following a 7 to 14 days screening/washout period, placebo-matching cariprazine capsule, one per day, orally for 6 weeks.
    Intervention: Drug: Placebo
  • Experimental: Cariprazine 1.5 mg
    Following a 7 to 14 days screening/washout period, cariprazine 1.5 milligram (mg) capsule, one per day, orally for 6 weeks.
    Intervention: Drug: Cariprazine
  • Experimental: Cariprazine 3.0 mg
    Following a 7 to 14 days screening/washout period, cariprazine 1.5 mg capsule, one per day for 2 weeks followed by cariprazine 3.0 milligram (mg) capsule, one per day, orally beginning on Day 15 for 4 weeks.
    Intervention: Drug: Cariprazine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2017)
488
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2016)
480
Actual Study Completion Date  ICMJE July 19, 2017
Actual Primary Completion Date July 19, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 --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)

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: ○ 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Estonia,   Lithuania,   Poland,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02670551
Other Study ID Numbers  ICMJE RGH-MD-54
2016-000757-13 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Forest Laboratories
Study Sponsor  ICMJE Forest Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clincial Director Forest Research Institute, Inc., an affiliate of Allergan, plc
PRS Account Forest Laboratories
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP