Clinical Trial: Treatment of Depersonalization Disorder With Repetitive Transcranial Magnetic Stimulation (rTMS)
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Treatment of Depersonalization Disorder With Repetitive Transcranial Magnetic Stimulation (rTMS)
Brief Summary: This is a randomized controlled trial (RCT) on the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) in the treatment of Depersonalization Disorder (DPD). TMS applies a magnetic field to the brain for a brief period of time. TMS is a procedure that involves 30 minute-long daily sessions every weekday for a series of weeks. The investigators are testing whether TMS can treat Depersonalization Disorder (DPD).
Detailed Summary:
This study is a research trial of an outpatient, non-medication, non-invasive investigational treatment called Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive tool for the study of the human brain that has been approved by the FDA for use in depression, but it is also being investigated as a potential therapeutic agent for other symptoms, such as those seen in Depersonalization Disorder (DPD).
TMS applies a magnetic field to the brain for a brief period of time. TMS is a procedure that involves 30 minute-long daily sessions every weekday for a series of weeks. The investigators are testing whether TMS can treat Depersonalization Disorder (DPD).
In this trial, 32 adult outpatients with DPD, that have been only partially responsive to conventional therapies, will be treated with active or sham low frequency (1 Hz) rTMS applied to the right temporo-parietal junction (TPJ) daily for up to six weeks.
DPD symptoms will be monitored through weekly self-report questionnaires as well clinical ratings with a doctor.
Sponsor: New York State Psychiatric Institute
Current Primary Outcome: Cambridge Depersonalization Scale (CDS) [ Time Frame: Change from baseline after 6 weeks of active rTMS ]
The outcome of subjects randomized to active rTMS in phase 1 will be assessed as the change from baseline after 6 weeks of daily rTMS (week 6 assessment). Subjects randomized to receive sham in phase 1 will be assessed at baseline and week 6, but the primary method of assessing improvement will be the change between the baseline and week 12 scores (i.e. after receiving 6 weeks of active rTMS).
Scale item number: 29 Item score range: Frequency: 0 - 4, Duration: 0-5 Minimum CDS score: 0 Maximum CDS score: 261
Higher scores indicate the presence of high symptom severity. Decrease in scores from baseline reflects clinical symptom improvement.
Original Primary Outcome: Same as current
Current Secondary Outcome: Clinical Improvement (assessed by CGI-S) [ Time Frame: Change from baseline after 6 weeks of active rTMS ]
The outcome of subjects randomized to active rTMS in phase 1 will be assessed as the change from baseline after 6 weeks of daily rTMS (week 6 assessment). Subjects randomized to receive sham in phase 1 will be assessed at baseline and week 6, but the primary method of assessing improvement will be the change between the baseline and week 12 scores (i.e. after receiving 6 weeks of active rTMS).
Minimum CGI-S score: 1 Maximum CGI-S score: 7
Higher scores indicate the presence of high symptom severity. Decrease in scores from baseline reflects clinical symptom improvement.
Patients will be classified as responders with a CGI-S = 1 or 2; and partial responders CGI-S = 3.
- = Normal, not at all ill
- = Borderline mentally ill
- = Mildly ill
- = Moderately ill
- = Markedly ill
- = Severely ill
- = Among the most extremely ill patients
Original Secondary Outcome: Same as current
Information By: New York State Psychiatric Institute
Dates:
Date Received: August 21, 2014
Date Started: October 2013
Date Completion:
Last Updated: January 12, 2017
Last Verified: January 2017
