Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS) (TMS)
Primary Purpose
Depersonalization Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation (rTMS)
Sponsored by
About this trial
This is an interventional treatment trial for Depersonalization Disorder focused on measuring Dissociative, Dissociation, Depersonalization, Depersonalization Disorder, Transcranial Magnetic Stimulation, TMS, Depersonalization Disorder (DPD), rTMS
Eligibility Criteria
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
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open-Label Active rTMS
Arm Description
Active repetitive Transcranial Magnetic Stimulation (rTMS)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00529217
First Posted
September 13, 2007
Last Updated
September 16, 2014
Sponsor
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT00529217
Brief Title
Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS)
Acronym
TMS
Official Title
Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the clinical efficacy of transcranial magnetic stimulation in the treatment of Depersonalization Disorder (DPD).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depersonalization Disorder
Keywords
Dissociative, Dissociation, Depersonalization, Depersonalization Disorder, Transcranial Magnetic Stimulation, TMS, Depersonalization Disorder (DPD), rTMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open-Label Active rTMS
Arm Type
Experimental
Arm Description
Active repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Other Intervention Name(s)
Magstim, Magstim Rapid, Magstim Rapid2
Intervention Description
Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
Primary Outcome Measure Information:
Title
Cambridge Depersonalization Scale (CDS)
Description
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.
Time Frame
6, 9, or 12 weeks
Secondary Outcome Measure Information:
Title
Clinical Improvement (CGI-S)
Description
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
Time Frame
6, 9, or 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Mantovani, MD
Organizational Affiliation
Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15659590
Citation
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.
Results Reference
background
PubMed Identifier
9153480
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. doi: 10.1212/wnl.48.5.1398.
Results Reference
background
PubMed Identifier
16005701
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. doi: 10.1016/j.brat.2004.08.003.
Results Reference
background
PubMed Identifier
15115950
Citation
Jimenez-Genchi AM. Repetitive transcranial magnetic stimulation improves depersonalization: a case report. CNS Spectr. 2004 May;9(5):375-6. doi: 10.1017/s1092852900009366.
Results Reference
background
PubMed Identifier
12680746
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. doi: 10.1177/0269881103017001712.
Results Reference
background
PubMed Identifier
11058475
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. doi: 10.1176/appi.ajp.157.11.1782.
Results Reference
background
PubMed Identifier
15231553
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. doi: 10.1192/bjp.185.1.31.
Results Reference
background
PubMed Identifier
15876908
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. doi: 10.1097/01.jcp.0000162803.61700.4f.
Results Reference
background
PubMed Identifier
15089102
Citation
Simeon D. Depersonalisation disorder: a contemporary overview. CNS Drugs. 2004;18(6):343-54. doi: 10.2165/00023210-200418060-00002.
Results Reference
background
PubMed Identifier
9474057
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. doi: 10.1016/s0168-5597(97)00096-8.
Results Reference
background
Links:
URL
http://www.brainstimulation.columbia.edu/
Description
Division of Brain Stimulation and Therapeutic Modulation web site
Learn more about this trial
Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS)
We'll reach out to this number within 24 hrs