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| Name | Class |
|---|---|
| City University of New York, School of Public Health | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham rTMS | Sham Comparator | Daily rTMS with Sham coil 30 minutes of 1Hz rTMS, 5 days per week, for 6 weeks with Sham (placebo) coil |
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| Active rTMS | Experimental | Daily rTMS with Active coil 30 minutes of 1Hz rTMS, 5 days per week, for 6 weeks with active coil |
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| Open Active rTMS | Experimental | Open Label Daily rTMS with Active coil 30 minutes of 1Hz rTMS, 5 days per week, for 6 weeks with active coil |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily rTMS with Active coil | Device | rTMS produces strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for six weeks |
| 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 |
| 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.
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Mantovani, MD, PhD | City University of New York | Principal Investigator |
| Daniel Javitt, MD, PhD | New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sophie Davis School of Biomedical Education, City University of New York (CUNY) | New York | New York | 10031 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15659590 | Background | 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. doi: 10.1523/JNEUROSCI.2612-04.2005. | |
| 9153480 | Background | 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. doi: 10.1212/wnl.48.5.1398. |
| Label | URL |
|---|---|
| Department of Psychiatry, Columbia University Medical Center | View source |
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| Daily rTMS with Sham coil | Device | rTMS produces strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for six weeks |
|
|
| Open Label Daily rTMS with Active coil | Device | rTMS produces strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for six weeks |
|
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| Change from baseline after 6 weeks of active rTMS |
| New York State Psychiatric Institute, Experimental Therapeutics |
| New York |
| New York |
| 10032 |
| United States |
| 16005701 | Background | 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. doi: 10.1016/j.brat.2004.08.003. |
| 15115950 | Background | Jimenez-Genchi AM. Repetitive transcranial magnetic stimulation improves depersonalization: a case report. CNS Spectr. 2004 May;9(5):375-6. doi: 10.1017/s1092852900009366. |
| 12680746 | Background | 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. doi: 10.1177/0269881103017001712. |
| 11058475 | Background | 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. doi: 10.1176/appi.ajp.157.11.1782. |
| 15231553 | Background | Simeon D, Guralnik O, Schmeidler J, Knutelska M. Fluoxetine therapy in depersonalisation disorder: randomised controlled trial. Br J Psychiatry. 2004 Jul;185:31-6. doi: 10.1192/bjp.185.1.31. |
| 15876908 | Background | Simeon D, Knutelska M. An open trial of naltrexone in the treatment of depersonalization disorder. J Clin Psychopharmacol. 2005 Jun;25(3):267-70. doi: 10.1097/01.jcp.0000162803.61700.4f. |
| 15089102 | Background | Simeon D. Depersonalisation disorder: a contemporary overview. CNS Drugs. 2004;18(6):343-54. doi: 10.2165/00023210-200418060-00002. |
| 9474057 | Background | 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. doi: 10.1016/s0168-5597(97)00096-8. |
| 19833552 | Background | 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. |
| 23941986 | Background | 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. No abstract available. |
| National Institute of Mental Health | View source |
| ID | Term |
|---|---|
| D003861 | Depersonalization |
| D004213 | Dissociative Disorders |
| D001526 | Behavioral Symptoms |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D001523 | Mental Disorders |
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