Safety, Tolerability, and Efficacy of Cariprazine in Patients With Bipolar Depression

This study has been completed.
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01396447
First received: July 15, 2011
Last updated: February 27, 2015
Last verified: February 2015

July 15, 2011
February 27, 2015
July 2011
January 2014   (final data collection date for primary outcome measure)
Change from Baseline in the Montgomery-Åsberg Depression Rating Scale total score at Week 6 [ Time Frame: Week 6 to Week 8 ] [ Designated as safety issue: No ]
Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Week 6 to Week 8 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01396447 on ClinicalTrials.gov Archive Site
Change from Baseline in the Clinical Global Impressions-Severity total score at Week 6 [ Time Frame: Week 6 to Week 8 ] [ Designated as safety issue: No ]
Clinical Global Impressions - Severity (CGI-S) [ Time Frame: Week 6 to Week 8 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety, Tolerability, and Efficacy of Cariprazine in Patients With Bipolar Depression
A Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Bipolar Depression

The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of patients with bipolar depression.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Depression, Bipolar
  • Drug: Placebo
    Placebo was supplied in capsules.
  • Drug: Cariprazine
    Cariprazine was supplied in capsules.
  • Placebo Comparator: Placebo
    Patients who meet eligibility criteria will be administered a once daily oral dose of placebo
    Intervention: Drug: Placebo
  • Experimental: Cariprazine 0.75 mg
    Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine
    Intervention: Drug: Cariprazine
  • Experimental: Cariprazine 1.5 mg
    Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine
    Intervention: Drug: Cariprazine
  • Experimental: Cariprazine 3.0 mg
    Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine
    Intervention: Drug: Cariprazine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
584
March 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who have provided informed consent prior to any study specific procedures.
  • Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview (SCID) for DSM-IV-TR bipolar I depression without psychotic features.
  • Patients with normal physical examination, laboratory, vital signs,and/ or echocardiogram (ECG).
  • Verified previous manic or mixed episode.
  • Patients with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥ 20.
  • Patients with a HAMD-17 item 1 score ≥ 2.
  • Patients with a Clinical Global Impression of Severity (CGI-S) score ≥ 4.

Exclusion Criteria:

  • Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous 6 months.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   Canada,   Colombia,   Russian Federation,   Ukraine
 
NCT01396447
RGH-MD-56, 2011-002334-39
No
Forest Laboratories
Forest Laboratories
Gedeon Richter Ltd.
Study Director: Alan Lipschitz, MD Forest Laboratories
Forest Laboratories
February 2015

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