Clinical Trial: Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS)
Brief Summary: The purpose of this study is to evaluate the clinical efficacy of transcranial magnetic stimulation in the treatment of 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 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).
This is an open-label study. All patients will receive active treatment. 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: 6, 9, or 12 weeks ]
Change on CDS from baseline. 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:
- Cambridge Depersonalization Scale (CDS) [ Time Frame: 6, 9, or 12 weeks ]
- Dissociative Experiences Scale (DES) [ Time Frame: 6, 9, or 12 weeks ]
- Clinician-Administered Dissociative States Scale (CADSS) [ Time Frame: 6, 9, or 12 weeks ]
- Clinical Global Impression (CGI) [ Time Frame: 6, 9, or 12 weeks ]
Current Secondary Outcome: Clinical Improvement (CGI-S) [ Time Frame: 6, 9, or 12 weeks ]
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: Clinical Improvement [ Time Frame: 6, 9, or 12 weeks ]
Information By: New York State Psychiatric Institute
Dates:
Date Received: September 13, 2007
Date Started: May 2006
Date Completion:
Last Updated: September 16, 2014
Last Verified: November 2013
