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Trial record 1 of 4 for:    "Depersonalization disorder"
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Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS) (TMS)

This study has been completed.
Information provided by (Responsible Party):
New York State Psychiatric Institute Identifier:
First received: September 13, 2007
Last updated: September 16, 2014
Last verified: November 2013
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: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS)

Resource links provided by NLM:

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 ]

    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.

Secondary Outcome Measures:
  • 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.

    1. = Normal, not at all ill
    2. = Borderline mentally ill
    3. = Mildly ill
    4. = Moderately ill
    5. = Markedly ill
    6. = Severely ill
    7. = Among the most extremely ill patients

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 rTMS
Active repetitive Transcranial Magnetic Stimulation (rTMS)
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.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00529217

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

Additional Information:

Responsible Party: New York State Psychiatric Institute Identifier: NCT00529217     History of Changes
Other Study ID Numbers: 5269
Study First Received: September 13, 2007
Results First Received: December 13, 2012
Last Updated: September 16, 2014

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

Additional relevant MeSH terms:
Pathologic Processes
Behavioral Symptoms processed this record on April 28, 2017