Depersonalization Disorder
Conditions
Keywords
Dissociative, Dissociation, Depersonalization, Depersonalization Disorder, Transcranial Magnetic Stimulation, TMS, Depersonalization Disorder (DPD), rTMS
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.
Interventions
DEVICERepetitive 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.
Sponsors
New York State Psychiatric Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cambridge Depersonalization Scale (CDS) | 6, 9, or 12 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical Improvement (CGI-S) | 6, 9, or 12 weeks | 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 |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the Brain Behavior Clinic of Columbia Psychiatry and the Depersonalization and Dissociation Program of Mount Sinai and Beth Israel Medical Centers in New York.
Pre-assignment details
No enrolled participant was excluded from the trial. Twelve outpatients entered the study.
Participants by arm
| Arm | Count |
|---|---|
| Open-Label Active 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. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Unable to adhere to study schedule | 2 |
Baseline characteristics
| Characteristic | Open-Label Active |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 33.6 years STANDARD_DEVIATION 12.9 |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: 6, 9, or 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Open-Label, rTMS, Active Coil | Cambridge Depersonalization Scale (CDS) | 6 responders (>50% reduction in CDS score) |
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. 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
Time frame: 6, 9, or 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Open-Label, rTMS, Active Coil | Clinical Improvement (CGI-S) | 6 responders (CGI-S = 1 or 2) |