Acupuncture as a Supplemental Treatment for Bipolar Depression

This study has been completed.

First Received on October 29, 2003. Last Updated on October 13, 2009 History of Changes

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00071669

Purpose

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

Condition	Intervention	Phase
Bipolar Disorder	Procedure: Acupuncture	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	Adjunctive Acupuncture as a Treatment for Bipolar Depression

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture Acute Bronchitis Bipolar Disorder Depression

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment:	30
Study Start Date:	November 2001

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071669

Locations

United States, Texas
Bipolar Disorder Clinic and Research Program
Dallas, Texas, United States, 75390

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

More Information

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00071669 History of Changes
Other Study ID Numbers:	R03 MH61589, DSIR AT-SO
Study First Received:	October 29, 2003
Last Updated:	October 13, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Mood Disorder
Acupuncture

Additional relevant MeSH terms:

Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic

Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on February 09, 2012