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Completed

NCT Number: NCT00616486

rTMS in Treatment of Obsessive Compulsive Disorder (OCD)

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.

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Key information

Conditions

Obsessive Compulsive Disorder Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Military Medical Academy, Sofia, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

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 names: rTMS machine (MagPro, Medtronic)

Sham (Placebo)

Device

Sham treatment will mimic active treatment mentioned above.

Other names: rTMS machine (MagPro, Medtronic).

Primary outcomes

  1. Yale-Brown Obsessive Compulsive Scale (YBOCS)

    Time frame: pre, week 1, 2, 4, 6, 8, 12

Secondary outcomes

  1. Clinical Global Impression

    Time frame: pre, week 1, 2, 4, 6, 8, 12

  2. Hamilton Depression Rating Scale-21(HDRS)

    Time frame: pre, week 1, 2, 4, 6, 8, 12

  3. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: pre, week 1, 2, 4, 6, 8, 12

  4. Hamilton Anxiety Rating Scale (HARS)

    Time frame: pre, week 1, 2, 4, 6, 8, 12

  5. SF-36 QOLS version (1)

    Time frame: pre, week 1, 2, 4, 6, 8, 12

  6. Visual Analogue Scale

    Time frame: pre, week 1, 2, 4, 6, 8, 12

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Collaborators

  • Dokuz Eylul University
  • Military Medical Academy, Bulgaria

Registry information

Official study 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).

Important dates

Study start
2008
Primary completion
2010
Study completion
2012
First posted
Feb 15, 2008
Registry last updated
Dec 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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