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

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ClinicalTrials.gov Identifier: NCT00095745
Recruitment Status : Completed
First Posted : November 9, 2004
Last Update Posted : November 8, 2013
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Antidepressant + Aripiprazole Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1002 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2004
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
No Intervention: Antidepressant + Aripiprazole Drug: Antidepressant + Aripiprazole
Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-30mg Aripiprazole, once daily, 52-weeks.
Other Name: Abilify




Primary Outcome Measures :
  1. Safety assessments [ Time Frame: throughout the study ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095745


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00095745     History of Changes
Other Study ID Numbers: CN138-164
First Posted: November 9, 2004    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: April 2011

Additional relevant MeSH terms:
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Aripiprazole
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists