High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Post-traumatic Stress Disorder (PTSD)

Queen's University2 sites in 2 countries15 target enrollmentJanuary 2008

ConditionsPost-Traumatic Stress Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Post-Traumatic Stress Disorder
Sponsor: Queen's University
Enrollment: 15
Locations: 2
Primary Endpoint: Clinician Administered PTSD Scale (CAPS) in both active and sham groups
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

November 2012

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Queen's University

Responsible Party

Principal Investigator

Dr. Roumen Milev

Professor of Psychiatry and Psychology, Head, Department of Psychiatry Queen's University

Queen's University

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
•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 ≥
•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.

Outcomes

Primary Outcomes

Clinician Administered PTSD Scale (CAPS) in both active and sham groups

Time Frame: pre, week 2,4,6,8 & 12

Secondary Outcomes

Hamilton Depression Rating Scale(Pre, week 2,4,6,8 & 12)
Treatment Outcome PTSD scale (TOP-8)(Pre, week 2,4,6,8 & 12)
Hamilton Anxiety Scale(Pre, week 2,4,6,8 & 12)
Pittsburgh Sleep Quality Index(Pre, week 2,4,6,8 & 12)
PTSD Checklist-civilian (PCL-C)(Pre, week 2,4,6,8 & 12)
Clinical Global Impression Scale (both severity and improvement)(Pre, week 2,4,6,8 & 12)
Social Functioning-36 Quality of Life Scale version(1)(Pre, week 2,4,6,8 & 12)