Clinical trial NCT00529217: Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS)
Official title: Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depersonalization Disorder
Keywords: Dissociative
Dissociation
Depersonalization
Depersonalization Disorder
Transcranial Magnetic Stimulation
TMS
Depersonalization Disorder (DPD)
rTMS
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2007-09-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 description: 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.

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

Primary outcomes:
measure: Cambridge Depersonalization Scale (CDS)
timeFrame: 6, 9, or 12 weeks
Secondary outcomes:
measure: Clinical Improvement (CGI-S)
timeFrame: 6, 9, or 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Columbia
name: Antonio Mantovani, MD
role: PRINCIPAL_INVESTIGATOR
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