Trial record 1 of 2 for:    "Depersonalization disorder"
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Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00529217
First received: September 13, 2007
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

The purpose of this study is to evaluate the clinical efficacy of transcranial magnetic stimulation in the treatment of Depersonalization Disorder (DPD).


Condition Intervention Phase
Depersonalization Disorder
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS)

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Cambridge Depersonalization Scale (CDS) [ Time Frame: 6, 9, or 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Improvement [ Time Frame: 6, 9, or 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: May 2006
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open-Label Active Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
Other Name: Magstim, Magstim Rapid, Magstim Rapid2

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00529217

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Antonio Mantovani, MD Columbia
  More Information

Additional Information:
Publications:

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00529217     History of Changes
Other Study ID Numbers: 5269
Study First Received: September 13, 2007
Last Updated: March 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
Dissociative
Dissociation
Depersonalization
Depersonalization Disorder
Transcranial Magnetic Stimulation
TMS
Depersonalization Disorder (DPD)
rTMS

Additional relevant MeSH terms:
Depersonalization
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 23, 2014