A Long-Term Study of Aripiprazole in Patients With Major Depressive Disorder

November 7, 2013 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

A Multicenter, Long-Term, Open-label, Study to Assess the Safety and Tolerability of Aripiprazole as an Adjunctive Therapy in the Treatment of Outpatients With Major Depressive Disorder

This trial is a 52-week safety study to evaluate the safety of adjunctive aripiprazole in outpatients with major depressive disorder who have experienced an incomplete response to an ongoing antidepressant trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1002

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States
        • Local Institution
      • Peoria, Arizona, United States
        • Local Institution
    • California
      • Beverly Hills, California, United States
        • Local Institution
      • Burbank, California, United States
        • Local Institution
      • Encino, California, United States
        • Local Institution
      • Garden Grove, California, United States
        • Local Institution
      • National City, California, United States
        • Local Institution
      • Orange, California, United States
        • Local Institution
      • Pasadena, California, United States
        • Local Institution
      • Riverside, California, United States
        • Local Institution
      • San Diego, California, United States
        • Local Institution
    • Colorado
      • Denver, Colorado, United States
        • Local Institution
    • Connecticut
      • Farmington, Connecticut, United States
        • Local Institution
    • District of Columbia
      • Washington, District of Columbia, United States
        • Local Institution
    • Florida
      • Gainesville, Florida, United States
        • Local Institution
      • Jacksonville, Florida, United States
        • Local Institution
      • Orlando, Florida, United States
        • Local Institution
    • Georgia
      • Atlanta, Georgia, United States
        • Local Institution
      • Smyrna, Georgia, United States
        • Local Institution
    • Illinois
      • Chicago, Illinois, United States
        • Local Institution
      • Edwardsville, Illinois, United States
        • Local Institution
      • Oakbrook Terrace, Illinois, United States
        • Local Institution
    • Indiana
      • Terre Haute, Indiana, United States
        • Local Institution
    • Kansas
      • Overland Park, Kansas, United States
        • Local Institution
      • Wichita, Kansas, United States
        • Local Institution
    • Kentucky
      • Lexington, Kentucky, United States
        • Local Institution
    • Maryland
      • Rockville, Maryland, United States
        • Local Institution
    • Massachusetts
      • Springfield, Massachusetts, United States
        • Local Institution
    • Michigan
      • Farmington Hills, Michigan, United States
        • Local Institution
      • Okemos, Michigan, United States
        • Local Institution
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Local Institution
    • New York
      • Brooklyn, New York, United States
        • Local Institution
      • New York, New York, United States
        • Local Institution
      • Staten Island, New York, United States
        • Local Institution
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • Local Institution
      • Raleigh, North Carolina, United States
        • Local Institution
    • Ohio
      • Cincinnati, Ohio, United States
        • Local Institution
      • Toledo, Ohio, United States
        • Local Institution
    • Oregon
      • Portland, Oregon, United States
        • Local Institution
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Local Institution
      • Pittsburgh, Pennsylvania, United States
        • Local Institution
    • Rhode Island
      • East Providence, Rhode Island, United States
        • Local Institution
    • South Carolina
      • Charleston, South Carolina, United States
        • Local Institution
    • Tennessee
      • Memphis, Tennessee, United States
        • Local Institution
    • Texas
      • Austin, Texas, United States
        • Local Institution
      • Dallas, Texas, United States
        • Local Institution
      • Houston, Texas, United States
        • Local Institution
    • Utah
      • Salt Lake City, Utah, United States
        • Local Institution
    • Vermont
      • Woodstock, Vermont, United States
        • Local Institution
    • Virginia
      • Arlington, Virginia, United States
        • Local Institution
      • Charlottesville, Virginia, United States
        • Local Institution
      • Herndon, Virginia, United States
        • Local Institution
      • Richmond, Virginia, United States
        • Local Institution
    • Washington
      • Bellevue, Washington, United States
        • Local Institution
      • Seattle, Washington, United States
        • Local Institution
    • West Virginia
      • Morgantown, West Virginia, United States
        • Local Institution
    • Wisconsin
      • Brown Deer, Wisconsin, United States
        • Local Institution
      • Middleton, Wisconsin, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women, 18 years or older
  • Experiencing Major Depressive Disorder with a duration of minimally 8 weeks.
  • Treatment history of an inadequate response to at least one and no more than four antidepressants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Antidepressant + Aripiprazole
Drug: Antidepressant + Aripiprazole
Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-30mg Aripiprazole, once daily, 52-weeks.
Other Names:
  • Abilify

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety assessments
Time Frame: throughout the study
throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Otsuka America Pharmaceutical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (ACTUAL)

November 1, 2007

Study Completion (ACTUAL)

November 1, 2007

Study Registration Dates

First Submitted

November 9, 2004

First Submitted That Met QC Criteria

November 8, 2004

First Posted (ESTIMATE)

November 9, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

November 8, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN138-164

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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