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rTMS for Treatment of Depressed Phase of Bipolar Disorder Type II — rTMS  

Bipolar Disorder Clinical Trial

Official title:
rTMS (Repetitive Transcranial Magnetic Stimulation) for Acute Treatment of Depressed Phase of Bipolar Disorder Type II

Clinical Trial Summary

This research study evaluates an experimental device for the treatment of the depressed phase of Bipolar Disorder Type II. Repetitive Transcranial Magnetic Stimulation (rTMS) is an experimental procedure where a device delivers an alternating magnetic field to a focal area of the brain. When the coil is placed against the scalp on the left frontal area of the head, the magnetic field is focused to a region of the brain that is thought to be involved in depression. This study is intended to test if rTMS can affect this region of the brain in a way that improves the symptoms of depression related to Bipolar Disorder Type II. The purpose of this study is to obtain safety and efficacy information regarding the use of rTMS(Repetitive Transcranial Magnetic Stimulation) for patients in the depressed phase of Bipolar Disorder Type II.

Clinical Trial Description

This is a double-blind randomized controlled trial of rTMS for outpatients in the depressive phase of BD-II. Participants will be evaluated at UT Southwestern Medical Center at Dallas. Forty eligible subjects will be randomized to either active treatment (n=20) or sham (no stimulation, n=20). Each subject will receive treatment 5 days per week for a total of 6 weeks. At the end of the 6 weeks, those who remain depressed will have the option of receiving 6 additional weeks of open rTMS treatment. We require these participants to meet the same eligibility criteria in the open phase (i.e. MADRS ≥15, YMRS <12) as in the initial double blind phase. At the completion of treatment, a follow-up appointment will be scheduled with a study physician to ensure that the participant is properly transitioning to clinical care and is not having a significant change in clinical status. Those who do not already have a treating physician will be referred to a new provider. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00447096
Study type Interventional
Source University of Texas Southwestern Medical Center
Contact
Status Withdrawn
Phase Phase 2
Start date February 2007
Completion date February 2010
View Details
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