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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.

Study Description
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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

Study Design
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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

Arms and Interventions
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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


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

Eligibility Criteria
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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
Contacts and Locations
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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


  Show 58 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
 Antidepressive Agents
Aripiprazole
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs