Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00447096
Status:
WITHDRAWN
Last Update Posted:
2016-06-09
First Post:
2007-03-12
Brief Title:
rTMS for Treatment of Depressed Phase of Bipolar Disorder Type II
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
rTMS Repetitive Transcranial Magnetic Stimulation for Acute Treatment of Depressed Phase of Bipolar Disorder Type II
Status:
WITHDRAWN
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No results funding terminated and PI no longer at institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
rTMS
Brief 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 rTMSRepetitive Transcranial Magnetic Stimulation for patients in the depressed phase of Bipolar Disorder Type II
Detailed 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 n20 or sham no stimulation n20 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None