Skip to main content
Clinical Trials/NCT01540305
NCT01540305
Completed
Phase 2

A Randomized Double-blind Trial of Repetitive Transcranial Magnetic Stimulation in Obsessive -Compulsive Disorder With Three Months Follow-up

University of Brasilia1 site in 1 country22 target enrollmentMay 2011

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Obsessive Compulsive Disorder
Sponsor
University of Brasilia
Enrollment
22
Locations
1
Primary Endpoint
Changes in Y-BOCS scale scores relative to baseline
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2011
End Date
September 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Brasilia
Responsible Party
Principal Investigator
Principal Investigator

Joaquim Brasil-Neto

Dr.

University of Brasilia

Eligibility Criteria

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

Outcomes

Primary Outcomes

Changes in Y-BOCS scale scores relative to baseline

Time Frame: assessments were at baseline, at 2 weeks and at 3 months

Y-BOCS: Yale-Brown Obsessive-Compulsive Scale

Study Sites (1)

Loading locations...

Similar Trials