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

Bipolar Depression Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00363337
• Other study ID #: 1-Parker
• Status: Completed
• Phase: Phase 4
• First received: August 11, 2006
• Last updated: June 21, 2011
• Start date: August 2006
• Est. completion date: March 2009

Study information

• Verified date: June 2011
• Source: Lindner Center of HOPE
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Drug:
• aripiprazole
open label treatment with aripiprazole

Locations

Country	Name	City	State
United States	University of Cincinnati Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Lindner Center of HOPE	University of Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (1)

McElroy SL, Suppes T, Frye MA, Altshuler LL, Stanford K, Martens B, Leverich GS, Post RM, Keck PE Jr. Open-label aripiprazole in the treatment of acute bipolar depression: a prospective pilot trial. J Affect Disord. 2007 Aug;101(1-3):275-81. Epub 2007 Jan — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Asberg Depression Rating Scale (MADRS)		per protocol	No
Secondary	Clinical Global Impression Scale Modified for Bipolar Illness (CGI-BP)		per protocol	No