Treatment of Depersonalization Disorder With Repetitive Transcranial Magnetic Stimulation (rTMS)
NCT ID: NCT02256085
Last Updated: 2017-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2013-10-31
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Sham rTMS
Daily rTMS with Sham coil
30 minutes of 1Hz rTMS, 5 days per week, for 6 weeks with Sham (placebo) coil
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
Active rTMS
Daily rTMS with Active coil
30 minutes of 1Hz rTMS, 5 days per week, for 6 weeks with active coil
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
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
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
Interventions
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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
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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
No
Sponsors
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City University of New York, School of Public Health
OTHER
New York State Psychiatric Institute
OTHER
Responsible Party
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Principal Investigators
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Antonio Mantovani, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
City University of New York
Daniel Javitt, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
New York State Psychiatric Institute
Locations
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Sophie Davis School of Biomedical Education, City University of New York (CUNY)
New York, New York, United States
New York State Psychiatric Institute, Experimental Therapeutics
New York, New York, United States
Countries
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References
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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.
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.
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.
Jimenez-Genchi AM. Repetitive transcranial magnetic stimulation improves depersonalization: a case report. CNS Spectr. 2004 May;9(5):375-6. doi: 10.1017/s1092852900009366.
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.
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.
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.
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.
Simeon D. Depersonalisation disorder: a contemporary overview. CNS Drugs. 2004;18(6):343-54. doi: 10.2165/00023210-200418060-00002.
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.
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.
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.
Related Links
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Department of Psychiatry, Columbia University Medical Center
National Institute of Mental Health
Other Identifiers
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6818
Identifier Type: -
Identifier Source: org_study_id
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