rTMS in Treatment of Obsessive Compulsive Disorder (OCD)

Obsessive Compulsive Disorder Clinical Trial

Official title:

A Multicentre, Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy, Safety, and Clinical Outcomes of Low Frequency, Repetitive Transcranial Magnetic Stimulation (Over Supplementary Motor Area (SMA) Applied Bilaterally and Simultaneously) Versus Sham (Placebo rTMS) Treatment for 6 Weeks, When Added to a Stable Pharmacotherapy in Subjects With Obsessive Compulsive Disorder (OCD).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616486
• Other study ID #: psiy-266-07
• Status: Completed
• Phase: N/A
• First received: February 4, 2008
• Last updated: December 14, 2015
• Start date: January 2008
• Est. completion date: November 2012

Study information

• Verified date: December 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaBulgaria: Bulgarian Drug AgencyTurkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Low frequency (1Hz) rTMS applied bilaterally and simultaneously over SMA for 6 weeks in addition to the standard treatment regimen for OCD, will lead to significant improvement in patients' symptoms. The clinical improvement detected by YBOCS, CGI and SF-36 QOLS scores will be statistically significant in active treatment group compared to sham (placebo) treatment group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2012
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• signed patient informed consent;

• primary obsessive compulsive disorder;

• YBOCS score at least 20;

• males/females 18-65yrs;

• treated with adequate dose of SSRI at least 8 weeks at some stage of illness;

• currently using adequate, stable dose of SSRI at least 4 weeks but not responding.

Exclusion Criteria:

• schizophrenia, other psychotic disorders, bipolar I, current major depressive disorder (HDRS(17)>18, substance/alcohol dependence within last 6 months;

• severe axis II;

• suicidal score>=6 on MINI;

• metallic implant in cranium;

• severe/unstable medical conditions;

• not responding to ECT or had TMS in last 6 months;

• history epilepsy;

• neurological disorder leading to increased intracranial pressure;

• severe cardiac disorder/intracardiac lines, pacemakers;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

Device:
• repetitive transcranial magnetic stimulation
6 weeks of stimulation with RMT frequency 1Hz, intensity 110% of RMT for 20 minutes, 5 minutes of trains with 2 minutes of intra-train intervals to both SMA. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6.
• sham (placebo)
Sham treatment will mimic active treatment mentioned above.

Locations

Country	Name	City	State
Bulgaria	Military Medical Academy	Sofia
Canada	Providence Care, Mental Health Services	Kingston	Ontario
Turkey	Dokuz Eylul University	Izmir

Sponsors (3)

Lead Sponsor	Collaborator
Queen's University	Dokuz Eylul University, Military Medical Academy

Countries where clinical trial is conducted

Bulgaria,  Canada,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale-Brown Obsessive Compulsive Scale (YBOCS)		pre, week 1, 2, 4, 6, 8, 12	No
Secondary	Clinical Global Impression		pre, week 1, 2, 4, 6, 8, 12	No
Secondary	Hamilton Depression Rating Scale-21(HDRS)		pre, week 1, 2, 4, 6, 8, 12	No
Secondary	Pittsburgh Sleep Quality Index (PSQI)		pre, week 1, 2, 4, 6, 8, 12	No
Secondary	Hamilton Anxiety Rating Scale (HARS)		pre, week 1, 2, 4, 6, 8, 12	No
Secondary	SF-36 QOLS version (1)		pre, week 1, 2, 4, 6, 8, 12	No
Secondary	Visual Analogue Scale		pre, week 1, 2, 4, 6, 8, 12	No