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

Depersonalization Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02256085
• Other study ID #: 6818
• Status: Recruiting
• Phase: Phase 2
• First received: August 21, 2014
• Last updated: September 30, 2014
• Start date: October 2013
• Est. completion date: December 2016

Study information

• Verified date: September 2014
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• 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.

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depersonalization
• Depersonalization Disorder

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute, Experimental Therapeutics	New York	New York
United States	Sophie Davis School of Biomedical Education, City University of New York (CUNY)	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	City University of New York, School of Public Health

Country where clinical trial is conducted

United States, 

References & Publications (12)

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

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. — 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

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):2008-39. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14. Review. — 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

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.; = Normal, not at all ill; = Borderline mentally ill; = Mildly ill; = Moderately ill; = Markedly ill; = Severely ill; = Among the most extremely ill patients	Change from baseline after 6 weeks of active rTMS	No

External Links

•   Department of Psychiatry, Columbia University Medical Center
•   Division of Experimental Therapeutics (NYSPI) website
•   National Institute of Mental Health
•   Sophie Davis School of Biomedical Education, City University of New York (CUNY)