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NCT01396447 Clinical Trial

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

Depression, Bipolar Clinical Trial

Official title:
A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Bipolar Depression

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01396447
Other study ID # RGH-MD-56
Secondary ID 2011-002334-39
Status Completed
Phase Phase 2
First received
Last updated
Start date July 26, 2011
Est. completion date January 10, 2014

Study information
Verified date March 2018
Source Forest Laboratories
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Placebo was supplied in capsules.
• Cariprazine
Cariprazine was supplied in capsules.
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Sponsors (2)
Lead Sponsor Collaborator
Forest Laboratories Gedeon Richter Ltd.

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Colombia,  Russian Federation,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at 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. Baseline to Week 6
Secondary Change From Baseline in the Clinical Global Impressions-Severity Total Score at 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. Baseline to Week 6
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