Acupuncture as a Supplemental Treatment for Bipolar Depression

April 12, 2013 updated by: University of Texas Southwestern Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Study Registration Dates

First Submitted

October 29, 2003

First Submitted That Met QC Criteria

October 29, 2003

First Posted (Estimate)

October 30, 2003

Study Record Updates

Last Update Posted (Estimate)

April 15, 2013

Last Update Submitted That Met QC Criteria

April 12, 2013

Last Verified

November 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R03MH061589 (U.S. NIH Grant/Contract)
  • DSIR AT-SO (NorthShore LIJ Health System)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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