Acupuncture as a Supplemental Treatment for Bipolar Depre... | NCT00071669

Studies
Acupuncture as a Supplemental Treatment for Bipolar Depression

NCT00071669

Sponsor

University of Texas Southwestern Medical Center

Status

Completed

Last Update Posted

Apr 15, 2013Estimated

Enrollment

Phase

Phase 2

Conditions

Bipolar Disorder

Interventions

Acupuncture

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R03MH061589	U.S. NIH Grant/Contract		View source
DSIR AT-SO

Status Module

Record Verification Date

Nov 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2001

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 29, 2003

First Submission Date that Met QC Criteria

Oct 29, 2003

First Posted Date

Oct 30, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2013

Last Update Posted Date

Apr 15, 2013Estimated

Name	Class
National Institute of Mental Health (NIMH)	NIH

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Acupuncture	Procedure

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bipolar Disorder Clinic and Research Program		Dallas	Texas	75390	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19422756	Derived	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.

ID	Term
D001714	Bipolar Disorder
D019964	Mood Disorders

ID	Term
D000068105	Bipolar and Related Disorders
D001523	Mental Disorders

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics