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

NCT ID: NCT02256085

Last Updated: 2017-03-24

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-12-31

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.

Conditions

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Depersonalization Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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

Group Type SHAM_COMPARATOR

Daily rTMS with Sham coil

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

Daily rTMS with Active coil

Intervention Type 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 Active rTMS

Open Label Daily rTMS with Active coil

30 minutes of 1Hz rTMS, 5 days per week, for 6 weeks with active coil

Group Type EXPERIMENTAL

Open Label Daily rTMS with Active coil

Intervention Type DEVICE

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

Intervention Type 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

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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Magstim, Magstim Rapid, Magstim Rapid2 Magstim, Magstim Rapid, Magstim Rapid2 Magstim, Magstim Rapid, Magstim Rapid2

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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City University of New York, School of Public Health

OTHER

Sponsor Role collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

New York State Psychiatric Institute, Experimental Therapeutics

New York, New York, United States

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 15659590 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9153480 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16005701 (View on PubMed)

Jimenez-Genchi AM. Repetitive transcranial magnetic stimulation improves depersonalization: a case report. CNS Spectr. 2004 May;9(5):375-6. doi: 10.1017/s1092852900009366.

Reference Type BACKGROUND
PMID: 15115950 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12680746 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11058475 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15231553 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15876908 (View on PubMed)

Simeon D. Depersonalisation disorder: a contemporary overview. CNS Drugs. 2004;18(6):343-54. doi: 10.2165/00023210-200418060-00002.

Reference Type BACKGROUND
PMID: 15089102 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9474057 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19833552 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23941986 (View on PubMed)

Related Links

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http://columbiapsychiatry.org/

Department of Psychiatry, Columbia University Medical Center

http://www.nimh.nih.gov/index.shtml

National Institute of Mental Health

Other Identifiers

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6818

Identifier Type: -

Identifier Source: org_study_id

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