Efficacy Study of Transcranial Magnetic Stimulation for Treatment of Obsessive-Compulsive Disorder

Phase 2

Completed

• Conditions: Obsessive Compulsive Disorder

• Registration Number: NCT01540305
• Lead Sponsor: University of Brasilia

Brief Summary

This study aimed at verifying whether sessions of repetitive transcranial magnetic stimulation over a certain brain area (the supplementary motor area) could be useful in the relief of Obsessive-Compulsive Disorder symptoms.

Detailed Description

Patients were randomly administered either real (n = 12) or sham (n = 10) rTMS, once a day, 5 days a week, for 2 weeks. Randomization was performed according to a computer-generated schedule. Subjects and scale-rater physician were blind to treatment status of individuals. Only the rTMS administrator was aware of group allocations. Treatment response was assessed by self-and clinician-rated scales before treatment, immediately after treatment and 3 months thereafter, with the same examiner following a subject throughout the study. All patients included in the study had failed adequate pharmacological treatment for at least 2 antiobsessional drugs. Their prescription drugs were continued without change in dosage regimens throughout the study.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-02
• Study First Submitted: 2012-02-15
• Study First Submitted QC: 2012-02-27
• Last Update Submitted: 2012-02-27
• Study First Posted: 2012-02-28
• Last Update Posted: 2012-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• age 18 to 60 years
• diagnosis of obsessive-compulsive disorder (OCD) according to DSM-IV-TR criteria and having OCD of at least moderate severity (YBOCS score of 16 or above).

Exclusion Criteria

• subjects with comorbid psychiatric disorders (except depression - HAM-D ) or history of drug abuse
• significant head injury, or of any neurosurgical procedure
• pregnant women
• patients with metal implants or illnesses that prevent attendance to sessions
• patients with a history of seizure or bearing pacemakers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in Y-BOCS scale scores relative to baseline	assessments were at baseline, at 2 weeks and at 3 months	Y-BOCS: Yale-Brown Obsessive-Compulsive Scale

Trial Locations

Locations (1)

Laboratory of Neurosciences and Behavior, Biology Institute, University of Brasília; 🇧🇷 Brasília, DF, Brazil