Treatment of Depersonalization Disorder With Repetitive Transcranial Magnetic Stimulation (rTMS)



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 70
Updated:4/2/2016
Start Date:October 2013
End Date:December 2016

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This is a randomized controlled trial (RCT) on the efficacy of repetitive Transcranial
Magnetic Stimulation (rTMS) in the treatment of Depersonalization Disorder (DPD). 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 study is a research trial of an outpatient, non-medication, non-invasive
investigational treatment called Transcranial Magnetic Stimulation (TMS). TMS is a
noninvasive tool for the study of the human brain that has been approved by the FDA for use
in depression, but it is also being investigated as a potential therapeutic agent for other
symptoms, such as those seen in Depersonalization Disorder (DPD).

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).

In this trial, 32 adult outpatients with DPD, that have been only partially responsive to
conventional therapies, will be treated with active or sham low frequency (1 Hz) rTMS
applied to the right temporo-parietal junction (TPJ) daily for up to six weeks.

DPD symptoms will be monitored through weekly self-report questionnaires as well clinical
ratings with a doctor.

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.

- Patients must continue to be under the care of their treating psychiatrist who will
be writing prescriptions for concomitant medications through the duration of the
study.

- Capable and willing to provide informed consent

Exclusion Criteria:

- Individuals diagnosed with current Major Depressive Disorder or Panic Disorder.

- Individuals diagnosed with the following conditions: Bipolar Disorder (lifetime), any
Psychotic Disorder (lifetime), History of substance abuse or dependence within the
past yea (except nicotine and caffeine).

- Individuals with a neurological disorder including, but not limited to: brain lesion;
history of seizures; history of cerebrovascular accident; history of stroke; TIA,
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.

- History of treatment with rTMS therapy for any disorder.

- 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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