NCT00080314

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2004

Typical duration for phase_3

Geographic Reach
1 country

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2004

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

November 11, 2013

Status Verified

June 1, 2008

Enrollment Period

2.8 years

First QC Date

March 26, 2004

Last Update Submit

November 7, 2013

Conditions

Bipolar Disorder

Keywords

Bipolar 1 Disorder, depressed

Outcome Measures

Primary Outcomes (1)

  • Change on a depression rating scale at endpoint

Secondary Outcomes (1)

  • Response rate and Clinical Global Impression scale at endpoint

Study Arms (2)

A1

ACTIVE COMPARATOR
Drug: Aripiprazole

A2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AripiprazoleDRUG

Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks.

Also known as: Abilify
A1
PlaceboDRUG

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

A2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* ages 18-65 * Men and women, who have experienced a prior manic episode that required hospitalization, and now meet criteria for a major depressive episode.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (28)

Local Institution

Tuscaloosa, Alabama, United States

Location

Local Institution

Little Rock, Arkansas, United States

Location

Local Institution

San Diego, California, United States

Location

Local Institution

Sherman Oaks, California, United States

Location

Local Institution

Norwich, Connecticut, United States

Location

Local Institution

West Haven, Connecticut, United States

Location

Local Institution

Jacksonville, Florida, United States

Location

Local Institution

Maitland, Florida, United States

Location

Local Institution

Orlando, Florida, United States

Location

Local Insstitution

Honolulu, Hawaii, United States

Location

Local Institution

Chicago, Illinois, United States

Location

Local Institution

Lake Charles, Louisiana, United States

Location

Local Institution

Rockville, Maryland, United States

Location

Local Institution

Durham, North Carolina, United States

Location

Local Institution

Raleigh, North Carolina, United States

Location

Local Institution

Beachwood, Ohio, United States

Location

Local Institution

Dayton, Ohio, United States

Location

Local Institution

Oklahoma City, Oklahoma, United States

Location

Local Institution

Portland, Oregon, United States

Location

Local Institution

Media, Pennsylvania, United States

Location

Local Institution

Memphis, Tennessee, United States

Location

Local Institution

Austin, Texas, United States

Location

Local Institution

Dallas, Texas, United States

Location

Local Institution

Houston, Texas, United States

Location

Local Institution

Lake Jackson, Texas, United States

Location

Local Institution

Wichita Falls, Texas, United States

Location

Local Institution

Arlington, Virginia, United States

Location

Local Institution

Bellevue, Washington, United States

Location

MeSH Terms

Conditions

Bipolar DisorderConsciousness Disorders

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 26, 2004

First Posted

March 30, 2004

Study Start

January 1, 2004

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

November 11, 2013

Record last verified: 2008-06

Locations

US(28)