Clinical trial NCT01043900: Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) as an add-on Treatment for Resistant OCD
Official title: Right Prefrontal High Frequency rTMS in Treatment of Resistant OCD: a Double Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obsessive-Compulsive Disorder
Keywords: Obsessive-Compulsive Disorder
rTMS
Transcranial Magnetic Stimulation
treatment
randomized controlled trials
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2010-01-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: OCD is a chronic condition with a high rate of poor responders to conventional treatments, such as antidepressants and psychotherapy. Chronic symptoms can lead to important social impairment and suffering for patients and families.

The present study aims to investigate if the addition of transcranial magnetic stimulation can provide enhanced response to conventional treatment.

Transcranial magnetic stimulation is a noninvasive technique that can influence specific areas of the brain and has very few side effects.

Detailed description: The treatment with transcranial magnetic stimulation requires attendance to hospital daily sessions for 6 consecutive weeks. Each session lasts up to 30 minutes.

Side effects include scalp discomfort and mild headache. No anesthesia is required.

Stimulation aims the dorsolateral prefrontal cortex, a region previously studied to treat depression symptoms with positive results. The present technique has never been employed in previous studies, but risks are insignificant

Eligibility criteria: Inclusion Criteria:

* resistant OCD patients: maximum 25% reduction in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) scores after at least 3 adequate trials with serotonin reuptake inhibitors (SRI) (including clomipramine) and 20 hours of cognitive behavioral therapy (CBT) or documented intolerance to either treatment.

Exclusion Criteria:

* metallic cerebral implants
* history of severe trauma or brain injury
* organic brain disease
* severe somatic disease
* history of drug dependence
* chronic psychosis
* present manic state

Primary outcomes:
measure: A reduction of at least 30 % in the Yale-Brown Obsessive Compulsive Scale (YBOCS) scores and an "improved" or "much improved" score on the Clinical Global Impression (CGI) improvement scale by the end of follow-up
timeFrame: 3 - 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department and Institute of Psychiatry, General Hospital, University of São Paulo Medical School
name: Carlos G Mansur, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mansur CG, Myczkowki ML, de Barros Cabral S, Sartorelli Mdo C, Bellini BB, Dias AM, Bernik MA, Marcolin MA. Placebo effect after prefrontal magnetic stimulation in the treatment of resistant obsessive-compulsive disorder: a randomized controlled trial. Int J Neuropsychopharmacol. 2011 Nov;14(10):1389-97. doi: 10.1017/S1461145711000575. Epub 2011 Apr 18.