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

Obsessive-Compulsive Disorder Clinical Trial

— TDCSTOC  

Official title:

Transcranial Direct Current Stimulation as an add-on Treatment in SSRI-resistant Obsessive Compulsive Disorder : a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02407288
• Other study ID #: CSR G01
• Status: Recruiting
• Phase: N/A
• First received: March 30, 2015
• Last updated: May 4, 2017
• Start date: March 12, 2015
• Est. completion date: June 2018

Study information

• Verified date: May 2017
• Source: Hôpital le Vinatier
• Contact: Bation Remy, MD
• Phone: 33437915565
• Email: remy.bation[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Intervention

Device:
• transcranial dirrect current stimulation
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 tDCS

Locations

Country	Name	City	State
France	Centre Hospitalier Le Vinatier	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	score improvement on the Yale Brown Obsessive and Compulsive Scale after one month	% of improvement compare to baseline	1 month after treatment
Secondary	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)	1 month after treatment
Secondary	score improvement on the Yale Brown Obsessive and Compulsive Scale after 3 months	% of improvement compare to baseline	3 months after treatment