Clinical trial NCT03304600: tDCS for Treatment Resistant Obsessive Compulsive Disorder
Official title: Transcranial Direct Current Stimulation (tDCS) to Treat Patients With Severe and Resistant Obsessive Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
tDCS
Lead sponsor: Centre Hospitalier Henri Laborit
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2017-10-09
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 :

  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

Primary outcomes:
measure: Yale Brown Obsessive Compulsive Scale (YBOCS) score
timeFrame: 2 weeks
Secondary outcomes:
measure: Yale Brown Obsessive Compulsive Scale (YBOCS)
timeFrame: Month 1
measure: Yale Brown Obsessive Compulsive Scale (YBOCS),
timeFrame: Month 3
measure: Clinical Global Impression (CGI)
timeFrame: Month 1
measure: Clinical Global Impression (CGI)
timeFrame: Month 3
measure: Brown Assessment of Beliefs Scale (BABS)
timeFrame: Month 1
measure: Brown Assessment of Beliefs Scale (BABS)
timeFrame: Month 3
measure: Brief Anxiety Scale (BAS)
timeFrame: Month 1
measure: Brief Anxiety Scale (BAS)
timeFrame: Month 3
measure: Montgomery and Asberg Depression Rating Scale (MADRS)
timeFrame: Month 1
measure: Montgomery and Asberg Depression Rating Scale (MADRS)
timeFrame: Month 3
measure: Hospital Anxiety and Depression scale (HAD)
timeFrame: Month 1
measure: Hospital Anxiety and Depression scale (HAD)
timeFrame: Month 3
measure: Sheehan Disability Scale, (SDS)
timeFrame: Month 1
measure: Sheehan Disability Scale, (SDS)
timeFrame: Month 3
Other outcomes:
measure: Number of adverse events
timeFrame: 3 Month
Locations:
city: Lyon
country: France
facility: Hospices Civils De Lyon
city: Nantes
country: France
facility: CHU de Nantes
city: Poitiers
country: France
facility: Centre Hospitalier Henri Laborit
city: Rennes
country: France
facility: C.H. Guillaume Regnier
Study officials:
affiliation: Centre Hospitalier Henri Laborit
name: Damien HEIT, MD
role: STUDY_DIRECTOR
References: