Trial record 1 of 5 for: "Depersonalization"

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Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS) (TMS)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

New York State Psychiatric Institute

ClinicalTrials.gov Identifier:

NCT00529217

First received: September 13, 2007

Last updated: September 16, 2014

Last verified: November 2013

History of Changes

Results First Received: December 13, 2012

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Depersonalization Disorder
Intervention:	Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from the Brain Behavior Clinic of Columbia Psychiatry and the Depersonalization and Dissociation Program of Mount Sinai and Beth Israel Medical Centers in New York.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No enrolled participant was excluded from the trial. Twelve outpatients entered the study.

Reporting Groups

	Description
Open-Label, rTMS, Active Coil	Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.

Participant Flow: Overall Study

	Open-Label, rTMS, Active Coil
STARTED	12
COMPLETED	8
NOT COMPLETED	4
Lack of Efficacy	2
Unable to adhere to study schedule	2

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Open-Label Active	Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.

Baseline Measures

	Open-Label Active
Overall Participants Analyzed [Units: Participants]	12

Age [Units: Participants]
<=18 years	0
Between 18 and 65 years	12
>=65 years	0

Age [Units: Years] Mean (Standard Deviation)	33.6 (12.9)

Gender [Units: Participants]
Female	3
Male	9

Region of Enrollment [Units: Participants]
United States	12

Outcome Measures

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1. Primary:

Cambridge Depersonalization Scale (CDS) [ Time Frame: 6, 9, or 12 weeks ]

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2. Secondary:

Clinical Improvement (CGI-S) [ Time Frame: 6, 9, or 12 weeks ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:

Name/Title: Dr. Antonio Mantovani
Organization: Columbia University Department of Psychiatry, City University of New York
phone: 212-650-5417
e-mail: AMantovani@med.cuny.edu

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.

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.

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.

Responsible Party:	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00529217 History of Changes
Other Study ID Numbers:	5269
Study First Received:	September 13, 2007
Results First Received:	December 13, 2012
Last Updated:	September 16, 2014

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