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Sponsors and Collaborators: |
University of Texas Southwestern Medical Center Stanley Medical Research Institute Neuronetics |
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Information provided by: | University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00447096 |
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.
Condition | Intervention | Phase |
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Bipolar Disorder |
Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | rTMS (Repetitive Transcranial Magnetic Stimulation) for Acute Treatment of Depressed Phase of Bipolar Disorder Type II |
Estimated Enrollment: | 40 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | February 2010 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
UT Southwestern Medical Center at Dallas | |
Dallas, Texas, United States, 75390 |
Principal Investigator: | F. Andrew Kozel, MD, MSCR | UT Southwestern Medical Center at Dallas |
Study ID Numbers: | 102006-040 |
Study First Received: | March 12, 2007 |
Last Updated: | June 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00447096 |
Health Authority: | United States: Institutional Review Board |
Bipolar Type II Depression rTMS |
Affective Disorders, Psychotic Depression Mental Disorders Bipolar Disorder |
Mood Disorders Psychotic Disorders Depressive Disorder |
Pathologic Processes Disease |