Trial Outcomes & Findings for Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS) (NCT NCT00529217)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

6, 9, or 12 weeks

Results posted on

2014-09-22

Participant Flow

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.

No enrolled participant was excluded from the trial. Twelve outpatients entered the study.

Participant milestones

Participant milestones
Measure	Open-Label, rTMS, Active Coil 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.
Overall Study STARTED	12
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Open-Label, rTMS, Active Coil 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.
Overall Study Lack of Efficacy	2
Overall Study Unable to adhere to study schedule	2

Baseline Characteristics

Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open-Label Active n=12 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	33.6 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Open-Label, rTMS, Active Coil n=12 Participants 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.
Cambridge Depersonalization Scale (CDS)	6 responders (>50% reduction in CDS score)

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Open-Label, rTMS, Active Coil n=12 Participants 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.
Clinical Improvement (CGI-S)	6 responders (CGI-S = 1 or 2)

Adverse Events

Open-Label Active

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Antonio Mantovani

Columbia University Department of Psychiatry, City University of New York

Phone: 212-650-5417

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place