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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01396447
First Posted: July 18, 2011
Last Update Posted: March 18, 2015
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.
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories
July 15, 2011
July 18, 2011
March 18, 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 ]
Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Week 6 to Week 8 ]
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 ]
Clinical Global Impressions - Severity (CGI-S) [ Time Frame: Week 6 to Week 8 ]
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Durgam S, Earley W, Lipschitz A, Guo H, Laszlovszky I, Németh G, Vieta E, Calabrese JR, Yatham LN. An 8-Week Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Bipolar I Depression. Am J Psychiatry. 2016 Mar 1;173(3):271-81. doi: 10.1176/appi.ajp.2015.15020164. Epub 2015 Nov 6.

*   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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Canada,   Colombia,   Russian Federation,   Ukraine,   United States
Argentina
 
NCT01396447
RGH-MD-56
2011-002334-39 ( EudraCT Number )
No
Not Provided
Not Provided
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