Treatment of Depersonalization Disorder With Repetitive Transcranial Magnetic Stimulation (rTMS)
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: Sham rTMS 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
rTMS produces strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for six weeks
Other Names:
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| Experimental: Active rTMS 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
rTMS produces strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for six weeks
Other Names:
|
| Experimental: Open Active rTMS 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
rTMS produces strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for six weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Cambridge Depersonalization Scale (CDS) [Change from baseline after 6 weeks of active rTMS]
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.
Secondary Outcome Measures
- Clinical Improvement (assessed by CGI-S) [Change from baseline after 6 weeks of active rTMS]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female outpatients, 18 to 70 years of age.
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Primary diagnosis of Depersonalization Disorder.
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Duration of the index episode of at least a year.
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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.
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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.
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Capable and willing to provide informed consent
Exclusion Criteria:
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Individuals diagnosed with current Major Depressive Disorder or Panic Disorder.
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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).
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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.
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Increased risk of seizure for any reason, including prior head trauma with loss of consciousness for 5 minutes or more
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Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
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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.
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History of treatment with rTMS therapy for any disorder.
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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.
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Known or suspected pregnancy.
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Women who are breast-feeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sophie Davis School of Biomedical Education, City University of New York (CUNY) | New York | New York | United States | 10031 |
| 2 | New York State Psychiatric Institute, Experimental Therapeutics | New York | New York | United States | 10032 |
Sponsors and Collaborators
- New York State Psychiatric Institute
- City University of New York, School of Public Health
Investigators
- Principal Investigator: Antonio Mantovani, MD, PhD, CUNY
- Principal Investigator: Daniel Javitt, MD, PhD, New York State Psychiatric Institute
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Blanke O, Mohr C, Michel CM, Pascual-Leone A, Brugger P, Seeck M, Landis T, Thut G. Linking out-of-body experience and self processing to mental own-body imagery at the temporoparietal junction. J Neurosci. 2005 Jan 19;25(3):550-7.
- Chen R, Classen J, Gerloff C, Celnik P, Wassermann EM, Hallett M, Cohen LG. Depression of motor cortex excitability by low-frequency transcranial magnetic stimulation. Neurology. 1997 May;48(5):1398-403.
- Christopeit M, Simeon D, Urban N, Gowatsky J, Lisanby SH, Mantovani A. Effects of repetitive transcranial magnetic stimulation (rTMS) on specific symptom clusters in depersonalization disorder (DPD). Brain Stimul. 2014 Jan-Feb;7(1):141-3. doi: 10.1016/j.brs.2013.07.006. Epub 2013 Aug 6.
- Hunter EC, Baker D, Phillips ML, Sierra M, David AS. Cognitive-behaviour therapy for depersonalisation disorder: an open study. Behav Res Ther. 2005 Sep;43(9):1121-30.
- Jiménez-Genchi AM. Repetitive transcranial magnetic stimulation improves depersonalization: a case report. CNS Spectr. 2004 May;9(5):375-6.
- Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14. Review.
- Sierra M, Phillips ML, Ivin G, Krystal J, David AS. A placebo-controlled, cross-over trial of lamotrigine in depersonalization disorder. J Psychopharmacol. 2003 Mar;17(1):103-5.
- Simeon D, Guralnik O, Hazlett EA, Spiegel-Cohen J, Hollander E, Buchsbaum MS. Feeling unreal: a PET study of depersonalization disorder. Am J Psychiatry. 2000 Nov;157(11):1782-8.
- Simeon D, Guralnik O, Schmeidler J, Knutelska M. Fluoxetine therapy in depersonalisation disorder: randomised controlled trial. Br J Psychiatry. 2004 Jul;185:31-6.
- Simeon D, Knutelska M. An open trial of naltrexone in the treatment of depersonalization disorder. J Clin Psychopharmacol. 2005 Jun;25(3):267-70.
- Simeon D. Depersonalisation disorder: a contemporary overview. CNS Drugs. 2004;18(6):343-54. Review.
- Wassermann EM. Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Electroencephalogr Clin Neurophysiol. 1998 Jan;108(1):1-16.
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