Back to resultsTreatment of Depersonalization Disorder With Repetitive Transcranial Magnetic Stimulation (rTMS)
Primary Purpose
Depersonalization Disorder
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Daily rTMS with Active coil
Daily rTMS with Sham coil
Open Label Daily rTMS with Active coil
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, DPD, rTMS, Behavioral Symptoms
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.
- 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
Sites / Locations
- Sophie Davis School of Biomedical Education, City University of New York (CUNY)
- New York State Psychiatric Institute, Experimental Therapeutics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Experimental
Experimental
Arm Label
Sham rTMS
Active rTMS
Open Active rTMS
Arm Description
Daily rTMS with Sham coil 30 minutes of 1Hz rTMS, 5 days per week, for 6 weeks with Sham (placebo) coil
Daily rTMS with Active coil 30 minutes of 1Hz rTMS, 5 days per week, for 6 weeks with active coil
Open Label Daily rTMS with Active coil 30 minutes of 1Hz rTMS, 5 days per week, for 6 weeks with active coil
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02256085
First Posted
August 21, 2014
Last Updated
January 12, 2017
Sponsor
New York State Psychiatric Institute
Collaborators
City University of New York, School of Public Health
1. Study Identification
Unique Protocol Identification Number
NCT02256085
Brief Title
Treatment of Depersonalization Disorder With Repetitive Transcranial Magnetic Stimulation (rTMS)
Official Title
Treatment of Depersonalization Disorder With Repetitive Transcranial Magnetic Stimulation (rTMS)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Withdrawn
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
City University of New York, School of Public Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
Detailed 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.
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, DPD, rTMS, Behavioral Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
Daily rTMS with Sham coil
30 minutes of 1Hz rTMS, 5 days per week, for 6 weeks with Sham (placebo) coil
Arm Title
Active rTMS
Arm Type
Experimental
Arm Description
Daily rTMS with Active coil
30 minutes of 1Hz rTMS, 5 days per week, for 6 weeks with active coil
Arm Title
Open Active rTMS
Arm Type
Experimental
Arm Description
Open Label Daily rTMS with Active coil
30 minutes of 1Hz rTMS, 5 days per week, for 6 weeks with active coil
Intervention Type
Device
Intervention Name(s)
Daily rTMS with Active coil
Other Intervention Name(s)
Magstim, Magstim Rapid, Magstim Rapid2
Intervention Description
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
Intervention Name(s)
Daily rTMS with Sham coil
Other Intervention Name(s)
Magstim, Magstim Rapid, Magstim Rapid2
Intervention Description
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
Intervention Name(s)
Open Label Daily rTMS with Active coil
Other Intervention Name(s)
Magstim, Magstim Rapid, Magstim Rapid2
Intervention Description
rTMS produces strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for six weeks
Primary Outcome Measure Information:
Title
Cambridge Depersonalization Scale (CDS)
Description
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.
Time Frame
Change from baseline after 6 weeks of active rTMS
Secondary Outcome Measure Information:
Title
Clinical Improvement (assessed by CGI-S)
Description
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
Time Frame
Change from baseline after 6 weeks of active rTMS
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Mantovani, MD, PhD
Organizational Affiliation
CUNY
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Javitt, MD, PhD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sophie Davis School of Biomedical Education, City University of New York (CUNY)
City
New York
State/Province
New York
ZIP/Postal Code
10031
Country
United States
Facility Name
New York State Psychiatric Institute, Experimental Therapeutics
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
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15659590
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Results Reference
background
Links:
URL
http://columbiapsychiatry.org/
Description
Department of Psychiatry, Columbia University Medical Center
URL
http://www.ccny.cuny.edu/sophiedavis/physpharmandneuro.cfm
Description
Sophie Davis School of Biomedical Education, City University of New York (CUNY)
URL
http://www.nimh.nih.gov/index.shtml
Description
National Institute of Mental Health
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Treatment of Depersonalization Disorder With Repetitive Transcranial Magnetic Stimulation (rTMS)
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