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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Depression, Bipolar

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Cariprazine


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants received placebo orally once a day for 8 weeks. | Drug: Placebo<br>* Placebo was supplied in capsules.<br>|
| Experimental: Cariprazine 0.75 mg<br>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. | Drug: Cariprazine<br>* Cariprazine was supplied in capsules.<br>|
| Experimental: Cariprazine 1.5 mg<br>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. | Drug: Cariprazine<br>* Cariprazine was supplied in capsules.<br>|
| Experimental: Cariprazine 3.0 mg<br>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. | Drug: Cariprazine<br>* Cariprazine was supplied in capsules.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar I disorder, Bipolar depression, Depression, Bipolar disorder