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rTMS in Treatment of Obsessive Compulsive Disorder (OCD)

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ClinicalTrials.gov Identifier: NCT00616486
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : December 16, 2015
Military Medical Academy
Dokuz Eylul University
Information provided by (Responsible Party):
Dr. Roumen Milev, Queen's University

Brief 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.

Condition or disease Intervention/treatment
Obsessive Compulsive Disorder Device: repetitive transcranial magnetic stimulation Device: sham (placebo)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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).
Study Start Date : January 2008
Primary Completion Date : May 2010
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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).

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

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

Information from the National Library of Medicine

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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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Roumen Milev, Professor of Psychiatry and Psychology, Head, Department of Psychiatry Queen's University, Queen's University
ClinicalTrials.gov Identifier: NCT00616486     History of Changes
Other Study ID Numbers: psiy-266-07
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders