rTMS in Treatment of Obsessive Compulsive Disorder (OCD)

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Obsessive Compulsive Disorder

Intervention / Treatment
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* Device: repetitive transcranial magnetic stimulation
* Device: sham (placebo)


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: repetitive transcranial magnetic stimulation<br>* 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.<br>* Other names: rTMS machine (MagPro, Medtronic);|
| Placebo Comparator: 2<br> | Device: sham (placebo)<br>* Sham treatment will mimic active treatment mentioned above.<br>* Other names: rTMS machine (MagPro, Medtronic).;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale-Brown Obsessive Compulsive Scale (YBOCS) |  | pre, week 1, 2, 4, 6, 8, 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression |  | pre, week 1, 2, 4, 6, 8, 12 | 
| Hamilton Depression Rating Scale-21(HDRS) |  | pre, week 1, 2, 4, 6, 8, 12 | 
| Pittsburgh Sleep Quality Index (PSQI) |  | pre, week 1, 2, 4, 6, 8, 12 | 
| Hamilton Anxiety Rating Scale (HARS) |  | pre, week 1, 2, 4, 6, 8, 12 | 
| SF-36 QOLS version (1) |  | pre, week 1, 2, 4, 6, 8, 12 | 
| Visual Analogue Scale |  | pre, week 1, 2, 4, 6, 8, 12 |