tDCS as an add-on Treatment in SSRI-resistant OCD

Hôpital le Vinatier46 enrolled

Overview

The purpose of this study is to determine whether tDCS is effective as an add-on treatment in SSRI-resistant patients with obsessive and compulsive disorder

Total number of scheduled patients to be recruited: 46 We used the effect size of the study of Ruffini and colleagues (2009) in which rTMS was used to target the left orbito frontal cortex to calculate the number of patients to be recruited. With a risk alpha of 5%, a power of 80%, the number of patients to be included was 46 with an anticipated rate of 10% of lost to follow-up patients. (calculation was made on the http://www.spc.univ-lyon1.fr/mfcalc/NSN/assistant.htm) Statistical analysis to address the primary and secondary objectives: Chi squared test will be applied for quantitative data.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Obsessive-Compulsive Disorder

Interventions

transcranial dirrect current stimulationDEVICE

The tDCS device will deliver a direct current of 2mA during 20 minutes. Cathode will be localized in front of the left orbito-frontal on the FP3 point according to the EEG international reference. Anode will be localized in front of the right cerebellum 3 cm below the inion and 1 cm right from the midline

Sham tDCSDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients diagnosed with OCD according to DSM V criteria * YBOCS score of 16 and above, stable (\<20% of variation) during at least one month. * have received for at least 12 weeks of which 6 weeks was either at the maximum tolerated dose or alternatively the manufacturer's recommended maxi- mum daily dose. * age between 18 and 70 * voluntary and competent to consent Exclusion Criteria: * Major depressive disorder diagnosed with the DSM V criteria with a MADRS score \>30 (actual) * schizophrenia and other psychotic disorder * drugs or alcohol abuse * acutely suicidal * significant head injury, or of any neurosurgical procedure with implanted material * pregnant women

Locations (1)

Centre Hospitalier Le Vinatier

Bron, France

RECRUITING

Outcomes

Primary Outcomes

score improvement on the Yale Brown Obsessive and Compulsive Scale after one month

% of improvement compare to baseline

Time frame: 1 month after treatment

Secondary Outcomes

Number of responders on the YBOCS

Number of responders (decrease \>35%) on the Yale Brown Obsessive and Compulsive Scale) or a score of 2 or less on the CGI-I (much or very much improved)

Time frame: 1 month after treatment

score improvement on the Yale Brown Obsessive and Compulsive Scale after 3 months

% of improvement compare to baseline

Time frame: 3 months after treatment

Central Contacts

Bation Remy, MD

CONTACT

33437915565 remy.bation@chu-lyon.fr

Data from ClinicalTrials.gov

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