Acupuncture as a Supplemental Treatment for Bipolar Depression - Tabular View

Tracking Information
First Received Date ^ICMJE	October 29, 2003
Last Updated Date	October 13, 2009
Start Date ^ICMJE	November 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00071669 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Acupuncture as a Supplemental Treatment for Bipolar Depression
Official Title ^ICMJE	Adjunctive Acupuncture as a Treatment for Bipolar Depression
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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Bipolar Disorder
Intervention ^ICMJE	Procedure: Acupuncture
Study Arms / Comparison Groups
Publications *	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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	30
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00071669
Responsible Party
Study ID Numbers ^ICMJE	R03 MH61589, DSIR AT-SO
Study Sponsor ^ICMJE	National Institute of Mental Health (NIMH)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Mental Health (NIMH)
Verification Date	November 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP