NCT00046384

Brief Summary

The purpose of this study is to learn if aripiprazole is effective in the treatment of patients with acute symptoms of Bipolar Disorder.

Trial Health

90
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 2002

Shorter than P25 for phase_3

Geographic Reach
2 countries

14 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

June 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2002

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
Last Updated

November 11, 2013

Status Verified

September 1, 2007

Enrollment Period

10 months

First QC Date

September 27, 2002

Last Update Submit

November 7, 2013

Conditions

Bipolar I Disorder

Interventions

aripiprazoleDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Patients with acute symptoms of Bipolar Disorder

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

Sponsors & Collaborators

Study Sites (14)

Local Institution

Scottsdale, Arizona, United States

Location

Local Institution

Little Rock, Arkansas, United States

Location

Local Institution

Chula Vista, California, United States

Location

Local Institution

Pico Rivera, California, United States

Location

Local Institution

Riverside, California, United States

Location

Local Institution

San Diego, California, United States

Location

Local Institution

Washington D.C., District of Columbia, United States

Location

Local Institution

Winter Park, Florida, United States

Location

Local Institution

Staten Island, New York, United States

Location

Local Institution

Oklahoma City, Oklahoma, United States

Location

Local Institution

Nashville, Tennessee, United States

Location

Local Institution

Falls Church, Virginia, United States

Location

Local Institution

Bellevue, Washington, United States

Location

Local Institution

Mendoza, Argentina

Location

MeSH Terms

Interventions

Aripiprazole

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 27, 2002

First Posted

October 1, 2002

Study Start

June 1, 2002

Primary Completion

April 1, 2003

Study Completion

April 1, 2003

Last Updated

November 11, 2013

Record last verified: 2007-09

Locations

US(13)AR(1)