Clinical trial NCT00685152: High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Post-traumatic Stress Disorder (PTSD)
Official title: High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Post-traumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2008-05-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 primary objective is to evaluate the change in PTSD symptoms before and after six weeks of high-frequency rTMS treatment as measured by the Clinician Administered PTSD Scale (CAPS) in both active and control groups.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Clinician Administered PTSD Scale (CAPS) in both active and sham groups
timeFrame: pre, week 2,4,6,8 & 12
Secondary outcomes:
measure: Treatment Outcome PTSD scale (TOP-8)
timeFrame: Pre, week 2,4,6,8 & 12
measure: Hamilton Anxiety Scale
timeFrame: Pre, week 2,4,6,8 & 12
measure: Hamilton Depression Rating Scale
timeFrame: Pre, week 2,4,6,8 & 12
measure: Clinical Global Impression Scale (both severity and improvement)
timeFrame: Pre, week 2,4,6,8 & 12
measure: Social Functioning-36 Quality of Life Scale version(1)
timeFrame: Pre, week 2,4,6,8 & 12
measure: Pittsburgh Sleep Quality Index
timeFrame: Pre, week 2,4,6,8 & 12
measure: PTSD Checklist-civilian (PCL-C)
timeFrame: Pre, week 2,4,6,8 & 12
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Dr. Dancho Dilkov
city: Kingston
country: Canada
facility: Providence Care Mental Health Services
state: Ontario
Study officials:
affiliation: Queen's University
name: Roumen Milev, MD
role: PRINCIPAL_INVESTIGATOR
References: