Status:
WITHDRAWN
Treatment of Depersonalization Disorder With Repetitive Transcranial Magnetic Stimulation (rTMS)
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
City University of New York, School of Public Health
Conditions:
Depersonalization Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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...
Detailed Description
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 h...
Eligibility Criteria
Inclusion
- Male or female outpatients, 18 to 70 years of age.
- Primary diagnosis of Depersonalization Disorder.
- Duration of the index episode of at least a year.
- Patients currently on DPD medication must be at the same stable dose(s) at least 2 months and be to continue at the same dose(s) through the duration of the study.
- Patients must continue to be under the care of their treating psychiatrist who will be writing prescriptions for concomitant medications through the duration of the study.
- Capable and willing to provide informed consent
Exclusion
- Individuals diagnosed with current Major Depressive Disorder or Panic Disorder.
- Individuals diagnosed with the following conditions: Bipolar Disorder (lifetime), any Psychotic Disorder (lifetime), History of substance abuse or dependence within the past yea (except nicotine and caffeine).
- Individuals with a neurological disorder including, but not limited to: brain lesion; history of seizures; history of cerebrovascular accident; history of stroke; TIA, cerebral aneurysm, Dementia; Parkinson's Disease; Huntington's chorea; Multiple Sclerosis.
- Increased risk of seizure for any reason, including prior head trauma with loss of consciousness for 5 minutes or more
- Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
- Intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
- History of treatment with rTMS therapy for any disorder.
- If participating in psychotherapy, must have been in stable treatment for at least three months prior to entry into the study, with no anticipation of change in frequency of therapeutic sessions, or the therapeutic focus over the duration of the rTMS trial.
- Known or suspected pregnancy.
- Women who are breast-feeding
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02256085
Start Date
October 1 2013
End Date
December 1 2016
Last Update
March 24 2017
Active Locations (2)
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1
Sophie Davis School of Biomedical Education, City University of New York (CUNY)
New York, New York, United States, 10031
2
New York State Psychiatric Institute, Experimental Therapeutics
New York, New York, United States, 10032