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

This study has been completed.

Sponsored by: University of Cincinnati
Information provided by: University of Cincinnati
ClinicalTrials.gov Identifier: NCT00363337
  Purpose

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 IV

MedlinePlus related topics:   Bipolar Disorder    Depression   

ChemIDplus related topics:   Aripiprazole   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363337

Locations
United States, Ohio
University of Cincinnati Medical Center    
      Cincinnati, Ohio, United States, 45267-0559

Sponsors and Collaborators
University of Cincinnati

Investigators
Principal Investigator:     Susan L McElroy, MD     University of Cincinnati    
  More Information


Study ID Numbers:   1-Parker
First Received:   August 11, 2006
Last Updated:   January 23, 2008
ClinicalTrials.gov Identifier:   NCT00363337
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Adults  
Bipolar Depression  
Bipolar Disorder  
Bipolar I
Bipolar II
Depression

Study placed in the following topic categories:
Affective Disorders, Psychotic
Depression
Mental Disorders
Bipolar Disorder
Mood Disorders
Psychotic Disorders
Aripiprazole
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:
Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




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