Phase 2
N=12
Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS)
Depersonalization Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00529217 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Cambridge Depersonalization Scale (CDS) — 6 responders (>50% reduction in CDS score)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cambridge Depersonalization Scale (CDS) |
6 | — |
| SECONDARY Clinical Improvement (CGI-S) |
6 | — |
Summary
The purpose of this study is to evaluate the clinical efficacy of transcranial magnetic stimulation in the treatment of Depersonalization Disorder (DPD).
Eligibility Criteria
Inclusion Criteria
- 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.
- Capable and willing to provide informed consent
Exclusion Criteria
- Individuals with a neurological disorder including, but not limited to: brain lesion; history of seizures; history of cerebrovascular accident; history of stroke; 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.
- 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
Data sourced from ClinicalTrials.gov (NCT00529217). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.