A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode

Phase 3WithdrawnNCT00338273

Otsuka Pharmaceutical Development & Commercialization, Inc.

Overview

The purpose of this study is to evaluate flexible doses (5-30 mg) of aripiprazole in patients with bipolar depression.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Bipolar Disorder

Interventions

AripiprazoleDRUG

Tablets, Oral, 5 - 30 mg, Once daily, 8 weeks.

PlaceboDRUG

Tablets, Oral, 0 mg, Once daily, 8 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Outpatients * Must sign informed consent prior to protocol-related procedures Exclusion Criteria: * Women who are pregnant, trying to become pregnant, or nursing * Significant risk of committing suicide * Any serious unstable medical conditions

Locations (8)

Local Institution

Durham, North Carolina, United States

Local Institution

Ahmedabad, Gujarat, India

Local Institution

Chennai, India

Local Institution

Delhi, India

Outcomes

Primary Outcomes

Mean change from baseline to endpoint (Week 8 last observation carried forward = LOCF) on the Montgomery-Asberg Depression Rating Scale (MADRS) total score

Secondary Outcomes

Mean change from baseline to endpoint on the Clinical Global Impression-Bipolar Version, severity of illness score (depression)

Data from ClinicalTrials.gov

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