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

Primary Purpose

Bipolar Disorder

Status
Withdrawn
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aripiprazole
Placebo
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar I disorder with major depressive episode

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A1

A2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 15, 2006
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00338273
Brief Title
A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients With Bipolar I Disorder With a Major Depressive Episode
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Withdrawn
Study Start Date
December 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar I disorder with major depressive episode

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A1
Arm Type
Active Comparator
Arm Title
A2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Tablets, Oral, 5 - 30 mg, Once daily, 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, Oral, 0 mg, Once daily, 8 weeks.
Primary Outcome Measure Information:
Title
Mean change from baseline to endpoint (Week 8 last observation carried forward = LOCF) on the Montgomery-Asberg Depression Rating Scale (MADRS) total score
Secondary Outcome Measure Information:
Title
Mean change from baseline to endpoint on the Clinical Global Impression-Bipolar Version, severity of illness score (depression)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Eligibility Criteria
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
Facility Information:
Facility Name
Local Institution
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Local Institution
City
Ahmedabad
State/Province
Gujarat
Country
India
Facility Name
Local Institution
City
Chennai
Country
India
Facility Name
Local Institution
City
Delhi
Country
India
Facility Name
Local Institution
City
Hyderabad
Country
India
Facility Name
Local Institution
City
Lucknow
Country
India
Facility Name
Local Institution
City
Mumbai
Country
India
Facility Name
Local Institution
City
Vishakhapatnam
Country
India

12. IPD Sharing Statement

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

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