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A Preliminary Study of the Effectiveness and Tolerability of Aripiprazole in Bipolar Depression

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ClinicalTrials.gov Identifier: NCT00363337
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : June 22, 2011
Sponsor:
Collaborator:
University of Cincinnati
Information provided by:
Lindner Center of HOPE

Brief Summary:
The specific aim of this study is to obtain preliminary evidence of the acute effectiveness and tolerability of aripiprazole in the treatment of bipolar depression.

Condition or disease Intervention/treatment Phase
Bipolar Depression Drug: aripiprazole Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: aripiprazole
    open label treatment with aripiprazole
    Other Name: Abilify


Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: per protocol ]

Secondary Outcome Measures :
  1. Clinical Global Impression Scale Modified for Bipolar Illness (CGI-BP) [ Time Frame: per protocol ]


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

Inclusion Criteria:

  • subjects must have bipolar I, II or NOS disorder as defined by DSM-IV-TR; must have clinical significant depressive symptoms and have failed one or more mood stabilizer trials; may or may not be receiving antimanic or mood stabilizing medications; subjects or legally authorized representative must sign the Informed Consent document after the nature of the trial has been fully explained; if female, subjects must be postmenopausal, surgically incapable of childbearing or practicing medically acceptable effective method(s) of contraception.

Exclusion Criteria:

  • subjects who do not have bipolar disorder by DSM-IV criteria; subjects with current DSM-IV Axis I diagnosis of delirium, dementia, amnesia or other cognitive disorders or a psychotic disorder; subjects with serious general medical illness; subjects who are allergic to or have demonstrated hypersensitivity to aripiprazole; women who are pregnant or nursing; subjects who have received an experimental drug or used an experimental device within 30 days; subjects who have a history of neurologic malignant syndrome.

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): NCT00363337


Locations
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0559
Sponsors and Collaborators
Lindner Center of HOPE
University of Cincinnati
Investigators
Principal Investigator: Susan L McElroy, MD University of Cincinnati

Publications of Results:
Responsible Party: Susan McElroy, Lindner Center of HOPE
ClinicalTrials.gov Identifier: NCT00363337     History of Changes
Other Study ID Numbers: 1-Parker
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: June 2011

Keywords provided by Lindner Center of HOPE:
Adults
Bipolar Depression
Bipolar Disorder
Bipolar I
Bipolar II
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs