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

This study has been completed.
University of Cincinnati
Information provided by:
Lindner Center of HOPE Identifier:
First received: August 11, 2006
Last updated: June 21, 2011
Last verified: June 2011
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 Intervention Phase
Bipolar Depression Drug: aripiprazole Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Lindner Center of HOPE:

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

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

Enrollment: 31
Study Start Date: August 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: aripiprazole
    open label treatment with aripiprazole
    Other Name: Abilify

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

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.
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Please refer to this study by its identifier: NCT00363337

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

Responsible Party: Susan McElroy, Lindner Center of HOPE Identifier: NCT00363337     History of Changes
Other Study ID Numbers: 1-Parker
Study First Received: August 11, 2006
Last Updated: June 21, 2011

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

Additional relevant MeSH terms:
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on August 22, 2017