Status:
COMPLETED
High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Post-traumatic Stress Disorder (PTSD)
Lead Sponsor:
Queen's University
Conditions:
Post-Traumatic Stress Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This is a double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of high-frequency (20Hz) rTMS applied to the right dorsolateral prefrontal cortex for 6 weeks. The prima...
Eligibility Criteria
Inclusion
- Signed Patient Information and Consent.
- Patients with primary Post-Traumatic Stress Disorder (as diagnosed by MINI) and DSM IV TR.
- Patients with CAPS score of at least 40.
- Males or females between 18-65 years of age.
- Patients not taking PTSD pharmacotherapy for at least last 2 weeks prior to commencing in the study or if they are taking PTSD pharmacotherapy it must be stable for at least 6 weeks prior to the start and not be changed during the 6 weeks of the study treatment phase.
- Individual or group supportive psychotherapy may continue during the study but will not be allowed to start new psychotherapy during the 6 weeks of the study treatment phase.
Exclusion
- Current primary Axis I disorder including Schizophrenia, Bipolar Disorder type I, Major Depressive Disorder.
- Other primary Axis I disorders which, in the opinion of the investigator, may affect the outcome of this study.
- Patients with HDRS score ≥ 18.
- A metallic implant in cranium (except the mouth).
- Patients with severe or unstable medical conditions, which in the opinion of the investigator would interfere with their progress or safety.
- ECT treatment within the last three months.
- Patients with a history of epilepsy.
- Patients with neurological disorder leading to increased intracranial pressure.
- Patients with severe cardiac disorder or intracardiac lines and pacemakers.
- Patients with current suicide risk ≥ 6 points by MINI.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00685152
Start Date
January 1 2008
End Date
November 1 2012
Last Update
December 16 2015
Active Locations (2)
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1
Dr. Dancho Dilkov
Sofia, Bulgaria
2
Providence Care Mental Health Services
Kingston, Ontario, Canada, K7L 4X3