Back to resultsAcupuncture as a Supplemental Treatment for Bipolar Depression
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Mood Disorder, Acupuncture
Eligibility 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
Sites / Locations
- Bipolar Disorder Clinic and Research Program
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00071669
First Posted
October 29, 2003
Last Updated
April 12, 2013
Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00071669
Brief Title
Acupuncture as a Supplemental Treatment for Bipolar Depression
Official Title
Adjunctive Acupuncture as a Treatment for Bipolar Depression
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness of acupuncture in the treatment of Bipolar Depression.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Mood Disorder, Acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Bipolar Disorder Clinic and Research Program
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19422756
Citation
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. doi: 10.4088/JCP.08m04208. Epub 2009 May 5.
Results Reference
derived
Learn more about this trial
Acupuncture as a Supplemental Treatment for Bipolar Depression
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