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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Depersonalization Disorder

Intervention / Treatment
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* Device: Daily rTMS with Active coil
* Device: Daily rTMS with Sham coil
* Device: Open Label Daily rTMS with Active coil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham rTMS<br>Daily rTMS with Sham coil 30 minutes of 1Hz rTMS, 5 days per week, for 6 weeks with Sham (placebo) coil | Device: Daily rTMS with Sham coil<br>* rTMS produces strong electromagnetic fields ( 2Tesla) generated briefly ( 1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for six weeks<br>* Other names: Magstim, Magstim Rapid, Magstim Rapid2;|
| Experimental: Active rTMS<br>Daily rTMS with Active coil 30 minutes of 1Hz rTMS, 5 days per week, for 6 weeks with active coil | Device: Daily rTMS with Active coil<br>* rTMS produces strong electromagnetic fields ( 2Tesla) generated briefly ( 1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for six weeks<br>* Other names: Magstim, Magstim Rapid, Magstim Rapid2;|
| Experimental: Open Active rTMS<br>Open Label Daily rTMS with Active coil 30 minutes of 1Hz rTMS, 5 days per week, for 6 weeks with active coil | Device: Open Label Daily rTMS with Active coil<br>* rTMS produces strong electromagnetic fields ( 2Tesla) generated briefly ( 1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for six weeks<br>* Other names: Magstim, Magstim Rapid, Magstim Rapid2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cambridge Depersonalization Scale (CDS) | The outcome of subjects randomized to active rTMS in phase 1 will be assessed as the change from baseline after 6 weeks of daily rTMS (week 6 assessment). Subjects randomized to receive sham in phase 1 will be assessed at baseline and week 6, but the primary method of assessing improvement will be the change between the baseline and week 12 scores (i.e. after receiving 6 weeks of active rTMS). 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. | Change from baseline after 6 weeks of active rTMS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Improvement (assessed by CGI-S) | The outcome of subjects randomized to active rTMS in phase 1 will be assessed as the change from baseline after 6 weeks of daily rTMS (week 6 assessment). Subjects randomized to receive sham in phase 1 will be assessed at baseline and week 6, but the primary method of assessing improvement will be the change between the baseline and week 12 scores (i.e. after receiving 6 weeks of active rTMS). 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 | Change from baseline after 6 weeks of active rTMS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dissociative, Dissociation, Depersonalization, Depersonalization Disorder, Transcranial Magnetic Stimulation, TMS, DPD, rTMS, Behavioral Symptoms