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rTMS in Treatment of Obsessive Compulsive Disorder (OCD)

Primary Purpose

Obsessive Compulsive Disorder

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation
sham (placebo)
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Military Medical Academy
  • Providence Care, Mental Health Services
  • Dokuz Eylul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Yale-Brown Obsessive Compulsive Scale (YBOCS)

Secondary Outcome Measures

Clinical Global Impression
Hamilton Depression Rating Scale-21(HDRS)
Pittsburgh Sleep Quality Index (PSQI)
Hamilton Anxiety Rating Scale (HARS)
SF-36 QOLS version (1)
Visual Analogue Scale

Full Information

First Posted
February 4, 2008
Last Updated
December 14, 2015
Sponsor
Queen's University
Collaborators
Military Medical Academy, Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT00616486
Brief Title
rTMS in Treatment of Obsessive Compulsive Disorder (OCD)
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 Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
Military Medical Academy, Dokuz Eylul University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
repetitive transcranial magnetic stimulation
Other Intervention Name(s)
rTMS machine (MagPro, Medtronic)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham (placebo)
Other Intervention Name(s)
rTMS machine (MagPro, Medtronic).
Intervention Description
Sham treatment will mimic active treatment mentioned above.
Primary Outcome Measure Information:
Title
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Time Frame
pre, week 1, 2, 4, 6, 8, 12
Secondary Outcome Measure Information:
Title
Clinical Global Impression
Time Frame
pre, week 1, 2, 4, 6, 8, 12
Title
Hamilton Depression Rating Scale-21(HDRS)
Time Frame
pre, week 1, 2, 4, 6, 8, 12
Title
Pittsburgh Sleep Quality Index (PSQI)
Time Frame
pre, week 1, 2, 4, 6, 8, 12
Title
Hamilton Anxiety Rating Scale (HARS)
Time Frame
pre, week 1, 2, 4, 6, 8, 12
Title
SF-36 QOLS version (1)
Time Frame
pre, week 1, 2, 4, 6, 8, 12
Title
Visual Analogue Scale
Time Frame
pre, week 1, 2, 4, 6, 8, 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roumen Milev, MD
Organizational Affiliation
Queen's University
Official's Role
Study Chair
Facility Information:
Facility Name
Military Medical Academy
City
Sofia
Country
Bulgaria
Facility Name
Providence Care, Mental Health Services
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 4X3
Country
Canada
Facility Name
Dokuz Eylul University
City
Izmir
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
27011177
Citation
Hawken ER, Dilkov D, Kaludiev E, Simek S, Zhang F, Milev R. Transcranial Magnetic Stimulation of the Supplementary Motor Area in the Treatment of Obsessive-Compulsive Disorder: A Multi-Site Study. Int J Mol Sci. 2016 Mar 22;17(3):420. doi: 10.3390/ijms17030420.
Results Reference
derived

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rTMS in Treatment of Obsessive Compulsive Disorder (OCD)

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