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

New York State Psychiatric Institute

Status and phase: Withdrawn; Phase 2

Conditions: Depersonalization Disorder

Treatments: Device: Daily rTMS with Sham coil; Device: Daily rTMS with Active coil; Device: Open Label Daily rTMS with Active coil

Study type: Interventional

Funder types: Other

Identifiers

NCT02256085

6818 (Other Identifier)

Details and patient eligibility

About

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).

Full description

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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0 participants in 3 patient groups

Sham rTMS

Sham Comparator group

Description:

Daily rTMS with Sham coil 30 minutes of 1Hz rTMS, 5 days per week, for 6 weeks with Sham (placebo) coil

Treatment:

Device: Daily rTMS with Sham coil

Active rTMS

Experimental group

Description:

Daily rTMS with Active coil 30 minutes of 1Hz rTMS, 5 days per week, for 6 weeks with active coil

Treatment:

Device: Daily rTMS with Active coil

Open Active rTMS

Experimental group

Description:

Open Label Daily rTMS with Active coil 30 minutes of 1Hz rTMS, 5 days per week, for 6 weeks with active coil

Treatment:

Device: Open Label Daily rTMS with Active coil