NCT03304600

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 9, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

November 3, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2022

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

4.3 years

First QC Date

September 29, 2017

Last Update Submit

April 21, 2022

Conditions

Obsessive-Compulsive Disorder

Keywords

OCDtDCS

Outcome Measures

Primary Outcomes (1)

  • Yale Brown Obsessive Compulsive Scale (YBOCS) score

    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

    2 weeks

Secondary Outcomes (14)

  • Yale Brown Obsessive Compulsive Scale (YBOCS)

    Month 1

  • Yale Brown Obsessive Compulsive Scale (YBOCS),

    Month 3

  • Clinical Global Impression (CGI)

    Month 1

  • Clinical Global Impression (CGI)

    Month 3

  • Brown Assessment of Beliefs Scale (BABS)

    Month 1

  • +9 more secondary outcomes

Other Outcomes (1)

  • Number of adverse events

    3 Month

Study Arms (2)

Active stimulation

EXPERIMENTAL

10 sessions (1 per day during 2 week) of active tDCS stimulation

Device: Active stimulation

Sham Stimulation

SHAM COMPARATOR

10 sessions (1 per day during 2 week) of sham stimulation

Device: Sham stimulation

Interventions

Active stimulationDEVICE

Patients will receive a tDCS stimulation during 30 mn with an intensity of 2 milliampere (mA).

Active stimulation
Sham stimulationDEVICE

Patients will receive a Sham stimulation during 30 mn

Sham Stimulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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),
  • Signed written inform consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospices Civils De Lyon

Lyon, France

Location

CHU de Nantes

Nantes, 44093, France

Location

Centre Hospitalier Henri Laborit

Poitiers, 86021, France

Location

C.H. Guillaume Regnier

Rennes, 35703, France

Location

Related Publications (1)

  • Harika-Germaneau G, Heit D, Drapier D, Sauvaget A, Bation R, Chatard A, Doolub D, Wassouf I, Langbour N, Jaafari N. Treating refractory obsessive compulsive disorder with cathodal transcranial direct current stimulation over the supplementary motor area: a large multisite randomized sham-controlled double-blind study. Front Psychiatry. 2024 May 17;15:1338594. doi: 10.3389/fpsyt.2024.1338594. eCollection 2024.

    PMID: 38827437DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Damien HEIT, MD

    Centre Hospitalier Henri Laborit

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2017

First Posted

October 9, 2017

Study Start

November 3, 2017

Primary Completion

February 24, 2022

Study Completion

February 24, 2022

Last Updated

April 22, 2022

Record last verified: 2022-04

Locations

FR(4)