Acupuncture as a Supplemental Treatment for Bipolar Depression

Bipolar Disorder Clinical Trial

Official title:

Adjunctive Acupuncture as a Treatment for Bipolar Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00071669
• Other study ID #: R03MH061589
• Secondary ID: R03MH061589DSIR
• Status: Completed
• Phase: Phase 2
• First received: October 29, 2003
• Last updated: April 12, 2013
• Start date: November 2001

Study information

• Verified date: November 2005
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Procedure:
• Acupuncture

Locations

Country	Name	City	State
United States	Bipolar Disorder Clinic and Research Program	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States,