Acupuncture as a Supplemental Treatment for Bipolar Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00071669
First received: October 29, 2003
Last updated: April 12, 2013
Last verified: November 2005

October 29, 2003
April 12, 2013
November 2001
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Complete list of historical versions of study NCT00071669 on ClinicalTrials.gov Archive Site
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Acupuncture as a Supplemental Treatment for Bipolar Depression
Adjunctive Acupuncture as a Treatment for Bipolar Depression

The purpose of this study is to evaluate the effectiveness of acupuncture in the treatment of Bipolar Depression.

Patients receive 8 weeks (12 sessions) of acupuncture treatment plus stable medication. Patients are randomly assigned to receive either acupuncture designed to relieve symptoms of depression or acupuncture designed to relieve some other legitimate physical condition. A comparison group of patients who take medication but do not receive acupuncture is assessed to evaluate the effectiveness of medication alone. Patients participate in clinical assessment each week, which includes visiting with a psychiatrist and completing symptom rating scales.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Bipolar Disorder
Procedure: Acupuncture
Not Provided
Dennehy EB, Schnyer R, Bernstein IH, Gonzalez R, Shivakumar G, Kelly DI, Snow DE, Sureddi S, Suppes T. The safety, acceptability, and effectiveness of acupuncture as an adjunctive treatment for acute symptoms in bipolar disorder. J Clin Psychiatry. 2009 Jun;70(6):897-905. Epub 2009 May 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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Inclusion Criteria:

  • Meet DSM-IV criteria for bipolar I disorder or bipolar II disorder
  • Demonstrate symptoms of depression as determined by a minimum score of 25 on the Inventory for Depressive Symptoms-Clinician Rated Scale
  • Have taken stable psychoactive medications for at least 30 days prior to study entry
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00071669
R03 MH61589, R03MH061589, DSIR AT-SO
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University of Texas Southwestern Medical Center
National Institute of Mental Health (NIMH)
Not Provided
University of Texas Southwestern Medical Center
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP