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

Not Applicable

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Device: Sham tDCS; Device: transcranial dirrect current stimulation

• Registration Number: NCT02407288
• Lead Sponsor: Hôpital le Vinatier

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2015-03-12
• Study First Submitted: 2015-03-30
• Study First Submitted QC: 2015-04-01
• Study First Posted: 2015-04-02
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-05-08
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHAM tDCS	Sham tDCS	The same procedure will be applied except that the tDCS device will only deliver a current stimulation for the 10 first seconds.
active tDCS	transcranial dirrect current stimulation	patients will received 2 sessions per day for 5 consecutive days. Each session will last 20 minutes. 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

Primary Outcome Measures

Name	Time	Method
score improvement on the Yale Brown Obsessive and Compulsive Scale after one month	1 month after treatment	% of improvement compare to baseline

Secondary Outcome Measures

Name	Time	Method
score improvement on the Yale Brown Obsessive and Compulsive Scale after 3 months	3 months after treatment	% of improvement compare to baseline
Number of responders on the YBOCS	1 month after treatment	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)

Trial Locations

Locations (1)

Centre Hospitalier Le Vinatier; 🇫🇷 Bron, France