Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS)

Depersonalization Disorder Clinical Trial

— TMS  

Official title:

Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00529217
• Other study ID #: 5269
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2007
• Last updated: September 16, 2014
• Start date: May 2006
• Est. completion date: October 2010

Study information

• Verified date: November 2013
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical efficacy of transcranial magnetic stimulation in the treatment of Depersonalization Disorder (DPD).

Description:

This study is a research trial of an outpatient, non-medication, non-invasive investigational treatment called Transcranial Magnetic Stimulation (TMS). 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 is an open-label study. All patients will receive active treatment. DPD symptoms will be monitored through weekly self-report questionnaires as well clinical ratings with a doctor.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

• Capable and willing to provide informed consent

Exclusion Criteria:

• Individuals with a neurological disorder including, but not limited to: brain lesion; history of seizures; history of cerebrovascular accident; history of stroke; 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.

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depersonalization
• Depersonalization Disorder
• Disease

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

Jiménez-Genchi AM. Repetitive transcranial magnetic stimulation improves depersonalization: a case report. CNS Spectr. 2004 May;9(5):375-6. — View Citation

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. — View Citation

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. — View Citation

Simeon D, Guralnik O, Schmeidler J, Knutelska M. Fluoxetine therapy in depersonalisation disorder: randomised controlled trial. Br J Psychiatry. 2004 Jul;185:31-6. — View Citation

Simeon D, Knutelska M. An open trial of naltrexone in the treatment of depersonalization disorder. J Clin Psychopharmacol. 2005 Jun;25(3):267-70. — View Citation

Simeon D. Depersonalisation disorder: a contemporary overview. CNS Drugs. 2004;18(6):343-54. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cambridge Depersonalization Scale (CDS)	Change on CDS from baseline. 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.	6, 9, or 12 weeks	No
Secondary	Clinical Improvement (CGI-S)	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	6, 9, or 12 weeks	No

External Links

•   Division of Brain Stimulation and Therapeutic Modulation web site