rTMS in Treatment of Obsessive Compulsive Disorder (OCD) - Full Text View

Sponsors and Collaborators:	Queen's University Military Medical Academy Dokuz Eylul University
Information provided by:	Queen's University
ClinicalTrials.gov Identifier:	NCT00616486

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)

MedlinePlus related topics: Anxiety Obsessive-Compulsive Disorder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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).

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 [ 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 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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.
2: Placebo Comparator	Device: sham (placebo) Sham treatment will mimic active treatment mentioned above.

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

Contacts

Contact: Roumen Milev, MD	(613) 546-1101 ext 5630	milevr@providencecare.ca
Contact: Ann Shea, RN	(613) 548-5567 ext 5898	sheaa@providencecare.ca

Locations

Bulgaria
Military Medical Academy	Recruiting
Sofia, Bulgaria
Contact: Dancho Dilkov, MD ddilkov@abv.bg
Canada, Ontario
Providence Care, Mental Health Services	Recruiting
Kingston, Ontario, Canada, K7L 4X3
Sub-Investigator: Regina Du Toit, MD
Sub-Investigator: Ruzica Jokic, MD
Sub-Investigator: Alan Lowe, MD
Sub-Investigator: Abdullah Al-Daoud, MBBS, SSC-Psych
Turkey
Dokuz Eylul University	Recruiting
Izmir, Turkey
Contact: Selcuk Simsek, MD secuk.simsek@deu.edu.tr

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:	Queen's University ( Dr. Roumen Milev )
Study ID Numbers:	psiy-266-07
Study First Received:	February 4, 2008
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00616486 History of Changes
Health Authority:	Canada: Health Canada; Bulgaria: Bulgarian Drug Agency; Turkey: Ethics Committee

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Obsessive-Compulsive Disorder

Additional relevant MeSH terms:

Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders
Obsessive-Compulsive Disorder

ClinicalTrials.gov processed this record on May 07, 2009