Acupuncture as a Supplemental Treatment for Bipolar Depression

NCT ID: NCT00071669

Last Updated: 2013-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Acupuncture

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Locations

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Bipolar Disorder Clinic and Research Program

Dallas, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 19422756 (View on PubMed)

Other Identifiers

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R03MH061589

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR AT-SO

Identifier Type: -

Identifier Source: secondary_id

R03MH061589

Identifier Type: NIH

Identifier Source: org_study_id

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