Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) as an add-on Treatment for Resistant OCD

NCT01043900 | Completed Phase 2

• 1 other identifier: cgmansur01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive Disorder; rTMS; Transcranial Magnetic Stimulation; treatment; randomized controlled trials

Outcome Measures

Primary Outcomes (1)

• 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

  3 - 6 months

Study Arms (2)

Sham rTMS

PLACEBO COMPARATOR

Patients with stable medication regimen receiving 30 daily sessions of PLACEBO rTMS delivered to the right dorsolateral prefrontal cortex

Procedure: repetitive transcranial magnetic stimulation (rTMS)

Active rTMS

ACTIVE COMPARATOR

Patients with stable medication regimen receiving 30 daily sessions of active rTMS delivered to the right dorsolateral prefrontal cortex

Procedure: repetitive transcranial magnetic stimulation (rTMS)

Interventions

repetitive transcranial magnetic stimulation (rTMS) PROCEDURE

30 daily sessions: each with 40 trains of 5 seconds at 10Hz, with a 25 second inter-train interval, at an intensity of 110% of motor threshold. Site: Right Dorsolateral Prefrontal Cortex

Also known as: TMS

Active rTMS; Sham rTMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Related Publications (1)

• 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.

  PMID: 21557884 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Carlos G Mansur, MD

  Department and Institute of Psychiatry, General Hospital, University of São Paulo Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: January 7, 2010
• Study Start: August 1, 2003
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: January 7, 2010

Record last verified: 2009-09