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

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ClinicalTrials.gov Identifier: NCT01396447
Recruitment Status : Completed
First Posted : July 18, 2011
Results First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories

July 15, 2011
July 18, 2011
March 29, 2018
May 1, 2018
May 1, 2018
July 26, 2011
January 10, 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: Baseline to Week 6 ]
The Montgomery-Åsberg Depression Rating Scale is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants 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 item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The scores on the 10 items are summed for a total score that can range from 0 to 60. A higher score indicates greater depression. A negative change score indicates improvement.
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: Baseline to Week 6 ]
The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change score indicates improvement.
Clinical Global Impressions - Severity (CGI-S) [ Time Frame: Week 6 to Week 8 ]
Not Provided
Not Provided
 
Safety, Tolerability, and Efficacy of Cariprazine in Participants 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 participants 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
    Participants received placebo orally once a day for 8 weeks.
    Intervention: Drug: Placebo
  • Experimental: Cariprazine 0.75 mg
    Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.
    Intervention: Drug: Cariprazine
  • Experimental: Cariprazine 1.5 mg
    Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.
    Intervention: Drug: Cariprazine
  • Experimental: Cariprazine 3.0 mg
    Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
    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
600
January 10, 2014
January 10, 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participants who have provided informed consent prior to any study specific procedures.
  • Participants 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) with a current with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration.
  • Participants with normal physical examination, laboratory, vital signs, and/or echocardiogram (ECG).
  • Verified previous manic or mixed episode.
  • Participants with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥ 20.
  • Participants with a HAMD-17 item 1 score ≥ 2.
  • Participants with a Clinical Global Impression of Severity (CGI-S) score ≥ 4.

Exclusion Criteria:

  • Participants 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.
  • Women who are pregnant or breast feeding
  • Participants with Young Mania Rating Scale (YMRS) total score > 10
  • Participants who have dementia, mental retardation, schizophrenia/schizoaffective disorder.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older 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: Willie Earley, MD Allergan
Forest Laboratories
March 2018

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