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Clinical Trials/NCT03304600
NCT03304600
Completed
Not Applicable

Transcranial Direct Current Stimulation (tDCS) to Treat Patients With Severe and Resistant Obsessive Compulsive Disorder

Centre Hospitalier Henri Laborit4 sites in 1 country83 target enrollmentNovember 3, 2017

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.

Registry
clinicaltrials.gov
Start Date
November 3, 2017
End Date
February 24, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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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