Clinical trial NCT01540305: Efficacy Study of Transcranial Magnetic Stimulation for Treatment of Obsessive-Compulsive Disorder
Official title: A Randomized Double-blind Trial of Repetitive Transcranial Magnetic Stimulation in Obsessive -Compulsive Disorder With Three Months Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obsessive Compulsive Disorder
Keywords: Obsessive Compulsive Disorder
Transcranial Magnetic Stimulation
Treatment
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2012-02-28
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in Y-BOCS scale scores relative to baseline
timeFrame: assessments were at baseline, at 2 weeks and at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: Laboratory of Neurosciences and Behavior, Biology Institute, University of Brasília
state: DF
Study officials:
affiliation: University of Brasilia
name: Joaquim Brasil-Neto, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Mantovani A, Simpson HB, Fallon BA, Rossi S, Lisanby SH. Randomized sham-controlled trial of repetitive transcranial magnetic stimulation in treatment-resistant obsessive-compulsive disorder. Int J Neuropsychopharmacol. 2010 Mar;13(2):217-27. doi: 10.1017/S1461145709990435. Epub 2009 Aug 20.
citation: Mantovani A, Lisanby SH, Pieraccini F, Ulivelli M, Castrogiovanni P, Rossi S. Repetitive transcranial magnetic stimulation (rTMS) in the treatment of obsessive-compulsive disorder (OCD) and Tourette's syndrome (TS). Int J Neuropsychopharmacol. 2006 Feb;9(1):95-100. doi: 10.1017/S1461145705005729. Epub 2005 Jun 28.