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Completed

NCT Number: NCT00529217

Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS)

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

Completed

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Key information

Conditions

Depersonalization Disorder Behavior Behavioral Symptoms Depersonalization Dissociative Disorders Mental Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Device

Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.

Other names: Magstim, Magstim Rapid, Magstim Rapid2

Primary outcomes

  1. 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 outcomes

  1. 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.

    • = Normal, not at all ill
    • = Borderline mentally ill
    • = Mildly ill
    • = Moderately ill
    • = Markedly ill
    • = Severely ill
    • = Among the most extremely ill patients

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Registry information

Acronym: TMS

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Sep 14, 2007
Registry last updated
Sep 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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