Obsessive-Compulsive Disorder
Conditions
Keywords
OCD, tDCS
Brief summary
It's a multicentric, randomized, controlled study concerning 100 patients with treatment-resistant obsessive compulsive disorders (OCD). The aim of this study is to evaluate the effect of transcranial direct current stimulation (tDCS) on OCD patients.
Interventions
DEVICEActive stimulation
Patients will receive a tDCS stimulation during 30 mn with an intensity of 2 milliampere (mA).
DEVICESham stimulation
Patients will receive a Sham stimulation during 30 mn
Sponsors
Ministry of Health, France
Centre Hospitalier Henri Laborit
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Meets criteria for obsessive compulsive disorder according to Diagnostic and Statistical Manual (DSM IV) with a good insight (BABS) * No current depressive and suicidal risks * No epileptic pathology * Age: Participants will be both males and females, 18-70 years of age included. * Chronic Obsessive compulsive disorder ( Total Y-BOCS\>20 or Y-BOCS one subscale \> 15) * Obsessive compulsive disorder resistant to pharmacology treatment : 1. at least 2 antidepressants (IRS type) (\> 12 weeks) 2. cognitive and comportment therapy since at least one year * Treatment stability (antidepressants) for more than 12 weeks without significant improvement. * Affiliation to a social security system (recipient or assignee), * Signed written inform consent form
Exclusion criteria
* Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception or who is nursing, * Patient under curators * Patient hospitalized under duress * Meets another diagnosis of axe 1 of DSM-IV * Current depressive or suicidal risks * Patient with any form of metal in the cranium, a pacemaker, skull defects, or skin lesions to the scalp (cuts, abrasions, rash) * Epileptic patient * Patient with a medical history of cranial trauma * Patient unable to give his or hers informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Yale Brown Obsessive Compulsive Scale (YBOCS) score | 2 weeks | The primary objective of the study is to compare the change in Yale Brown Obsessive Compulsive Scale (YBOCS) scores from baseline to the week 2 (post-tDCS treatment) visit, between the two treatments groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Yale Brown Obsessive Compulsive Scale (YBOCS) | Month 1 | i. Change from baseline to month 1 in Yale Brown Obsessive Compulsive Scale (YBOCS) scores, between treatment groups. |
| Yale Brown Obsessive Compulsive Scale (YBOCS), | Month 3 | ii. Response rate at month 3 in Yale Brown Obsessive Compulsive Scale (YBOCS) score from baseline, between treatment groups. |
| Clinical Global Impression (CGI) | Month 1 | Change from baseline to month 1 in above scales between treatment groups; |
| Brown Assessment of Beliefs Scale (BABS) | Month 1 | Change from baseline to month 1 in above scales between treatment groups; |
| Montgomery and Asberg Depression Rating Scale (MADRS) | Month 1 | Change from baseline to month 1 in above scales between treatment groups; |
| Hospital Anxiety and Depression scale (HAD) | Month 1 | Change from baseline to month 1 in above scales between treatment groups; |
| Sheehan Disability Scale, (SDS) | Month 1 | Change from baseline to month 1 in above scales between treatment groups; |
| Brief Anxiety Scale (BAS) | Month 1 | Change from baseline to month 1 in above scales between treatment groups; |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | 3 Month | Safety of the tDCS treatment : * assessed by physical examination during each tDCS session * any other adverse events (AEs) |
Countries
France
Outcome results
None listed