NCT03304600
Completed
Not Applicable
Transcranial Direct Current Stimulation (tDCS) to Treat Patients With Severe and Resistant Obsessive Compulsive Disorder
ConditionsObsessive-Compulsive Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obsessive-Compulsive Disorder
- Sponsor
- Centre Hospitalier Henri Laborit
- Enrollment
- 83
- Locations
- 4
- Primary Endpoint
- Yale Brown Obsessive Compulsive Scale (YBOCS) score
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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 :
- •at least 2 antidepressants (IRS type) (\> 12 weeks)
- •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),
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
Outcomes
Primary Outcomes
Yale Brown Obsessive Compulsive Scale (YBOCS) score
Time Frame: 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 Outcomes
- Brown Assessment of Beliefs Scale (BABS)(Month 3)
- Yale Brown Obsessive Compulsive Scale (YBOCS),(Month 3)
- Hospital Anxiety and Depression scale (HAD)(Month 3)
- Yale Brown Obsessive Compulsive Scale (YBOCS)(Month 1)
- Brief Anxiety Scale (BAS)(Month 3)
- Montgomery and Asberg Depression Rating Scale (MADRS)(Month 3)
- Sheehan Disability Scale, (SDS)(Month 3)
- Clinical Global Impression (CGI)(Month 3)
Study Sites (4)
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