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rTMS in Treatment of Obsessive Compulsive Disorder (OCD)

This study has been completed.
Military Medical Academy
Dokuz Eylul University
Information provided by (Responsible Party):
Dr. Roumen Milev, Queen's University Identifier:
First received: February 4, 2008
Last updated: December 14, 2015
Last verified: December 2015
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.

Condition Intervention
Obsessive Compulsive Disorder Device: repetitive transcranial magnetic stimulation Device: sham (placebo)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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).

Resource links provided by NLM:

Further study details as provided by Dr. Roumen Milev, Queen's University:

Primary Outcome Measures:
  • Yale-Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: pre, week 1, 2, 4, 6, 8, 12 ]

Secondary Outcome Measures:
  • Clinical Global Impression [ Time Frame: pre, week 1, 2, 4, 6, 8, 12 ]
  • Hamilton Depression Rating Scale-21(HDRS) [ Time Frame: pre, week 1, 2, 4, 6, 8, 12 ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: pre, week 1, 2, 4, 6, 8, 12 ]
  • Hamilton Anxiety Rating Scale (HARS) [ Time Frame: pre, week 1, 2, 4, 6, 8, 12 ]
  • SF-36 QOLS version (1) [ Time Frame: pre, week 1, 2, 4, 6, 8, 12 ]
  • Visual Analogue Scale [ Time Frame: pre, week 1, 2, 4, 6, 8, 12 ]

Enrollment: 24
Study Start Date: January 2008
Study Completion Date: November 2012
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.
Other Name: rTMS machine (MagPro, Medtronic)
Placebo Comparator: 2 Device: sham (placebo)
Sham treatment will mimic active treatment mentioned above.
Other Name: rTMS machine (MagPro, Medtronic).


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00616486

Military Medical Academy
Sofia, Bulgaria
Canada, Ontario
Providence Care, Mental Health Services
Kingston, Ontario, Canada, K7L 4X3
Dokuz Eylul University
Izmir, Turkey
Sponsors and Collaborators
Queen's University
Military Medical Academy
Dokuz Eylul University
Study Chair: Roumen Milev, MD Queen's University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Roumen Milev, Professor of Psychiatry and Psychology, Head, Department of Psychiatry Queen's University, Queen's University Identifier: NCT00616486     History of Changes
Other Study ID Numbers: psiy-266-07
Study First Received: February 4, 2008
Last Updated: December 14, 2015

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders processed this record on September 21, 2017