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rTMS in Treatment of Obsessive Compulsive Disorder (OCD)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Military Medical Academy
Dokuz Eylul University
Information provided by (Responsible Party):
Roumen Milev, Queen's University
ClinicalTrials.gov Identifier:
NCT00616486
First received: February 4, 2008
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Yale-Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: pre, week 1, 2, 4, 6, 8, 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression [ Time Frame: pre, week 1, 2, 4, 6, 8, 12 ] [ Designated as safety issue: No ]
  • Hamilton Depression Rating Scale-21(HDRS) [ Time Frame: pre, week 1, 2, 4, 6, 8, 12 ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: pre, week 1, 2, 4, 6, 8, 12 ] [ Designated as safety issue: No ]
  • Hamilton Anxiety Rating Scale (HARS) [ Time Frame: pre, week 1, 2, 4, 6, 8, 12 ] [ Designated as safety issue: No ]
  • SF-36 QOLS version (1) [ Time Frame: pre, week 1, 2, 4, 6, 8, 12 ] [ Designated as safety issue: No ]
  • Visual Analogue Scale [ Time Frame: pre, week 1, 2, 4, 6, 8, 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: January 2008
Estimated 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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616486

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

No publications provided

Responsible Party: 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
Study First Received: February 4, 2008
Last Updated: March 15, 2012
Health Authority: Canada: Health Canada
Bulgaria: Bulgarian Drug Agency
Turkey: Ethics Committee

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

ClinicalTrials.gov processed this record on May 16, 2013