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

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ClinicalTrials.gov Identifier: NCT02256085
Recruitment Status : Withdrawn
First Posted : October 3, 2014
Last Update Posted : March 24, 2017
Sponsor:
Collaborator:
City University of New York, School of Public Health
Information provided by (Responsible Party):
New York State Psychiatric Institute

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).

Condition or disease Intervention/treatment Phase
Depersonalization Disorder Device: Daily rTMS with Active coil Device: Daily rTMS with Sham coil Device: Open Label Daily rTMS with Active coil Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Depersonalization Disorder With Repetitive Transcranial Magnetic Stimulation (rTMS)
Study Start Date : October 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Sham rTMS

Daily rTMS with Sham coil

30 minutes of 1Hz rTMS, 5 days per week, for 6 weeks with Sham (placebo) coil

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
Other Name: Magstim, Magstim Rapid, Magstim Rapid2

Experimental: Active rTMS

Daily rTMS with Active coil

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

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
Other Name: Magstim, Magstim Rapid, Magstim Rapid2

Experimental: 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

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
Other Name: Magstim, Magstim Rapid, Magstim Rapid2




Primary Outcome Measures :
  1. Cambridge Depersonalization Scale (CDS) [ Time Frame: Change from baseline after 6 weeks of active rTMS ]

    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 :
  1. Clinical Improvement (assessed by CGI-S) [ Time Frame: Change from baseline after 6 weeks of active rTMS ]

    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.

    1. = Normal, not at all ill
    2. = Borderline mentally ill
    3. = Mildly ill
    4. = Moderately ill
    5. = Markedly ill
    6. = Severely ill
    7. = Among the most extremely ill patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02256085


Locations
United States, New York
Sophie Davis School of Biomedical Education, City University of New York (CUNY)
New York, New York, United States, 10031
New York State Psychiatric Institute, Experimental Therapeutics
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
City University of New York, School of Public Health
Investigators
Principal Investigator: Antonio Mantovani, MD, PhD CUNY
Principal Investigator: Daniel Javitt, MD, PhD New York State Psychiatric Institute

Additional Information:
Publications:

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02256085     History of Changes
Other Study ID Numbers: 6818
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: January 2017

Keywords provided by New York State Psychiatric Institute:
Dissociative
Dissociation
Depersonalization
Depersonalization Disorder
Transcranial Magnetic Stimulation
TMS
DPD
rTMS
Behavioral Symptoms

Additional relevant MeSH terms:
Disease
Depersonalization
Pathologic Processes
Behavioral Symptoms