Clinical trial NCT00616486: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive Compulsive Disorder
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Military Medical Academy, Bulgaria
name: Dokuz Eylul University
First posted: 2008-02-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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;

Primary outcomes:
measure: Yale-Brown Obsessive Compulsive Scale (YBOCS)
timeFrame: pre, week 1, 2, 4, 6, 8, 12
Secondary outcomes:
measure: Clinical Global Impression
timeFrame: pre, week 1, 2, 4, 6, 8, 12
measure: Hamilton Depression Rating Scale-21(HDRS)
timeFrame: pre, week 1, 2, 4, 6, 8, 12
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: pre, week 1, 2, 4, 6, 8, 12
measure: Hamilton Anxiety Rating Scale (HARS)
timeFrame: pre, week 1, 2, 4, 6, 8, 12
measure: SF-36 QOLS version (1)
timeFrame: pre, week 1, 2, 4, 6, 8, 12
measure: Visual Analogue Scale
timeFrame: pre, week 1, 2, 4, 6, 8, 12
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Military Medical Academy
city: Kingston
country: Canada
facility: Providence Care, Mental Health Services
state: Ontario
city: Izmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
affiliation: Queen's University
name: Roumen Milev, MD
role: STUDY_CHAIR
References:
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.