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

This study has been completed.
Sponsor:
Collaborator:
University of Cincinnati
Information provided by:
Lindner Center of HOPE
ClinicalTrials.gov Identifier:
NCT00363337
First received: August 11, 2006
Last updated: June 21, 2011
Last verified: June 2011
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression Scale Modified for Bipolar Illness (CGI-BP) [ Time Frame: per protocol ] [ Designated as safety issue: No ]

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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Susan McElroy, Lindner Center of HOPE
ClinicalTrials.gov Identifier: NCT00363337     History of Changes
Other Study ID Numbers: 1-Parker
Study First Received: August 11, 2006
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

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
Affective Disorders, Psychotic
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on October 01, 2014