NCT02407288

Brief Summary

The purpose of this study is to determine whether tDCS is effective as an add-on treatment in SSRI-resistant patients with obsessive and compulsive disorder

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 12, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

3.2 years

First QC Date

March 30, 2015

Last Update Submit

May 4, 2017

Conditions

Obsessive-Compulsive Disorder

Keywords

OCD

Outcome Measures

Primary Outcomes (1)

  • score improvement on the Yale Brown Obsessive and Compulsive Scale after one month

    % of improvement compare to baseline

    1 month after treatment

Secondary Outcomes (2)

  • Number of responders on the YBOCS

    1 month after treatment

  • score improvement on the Yale Brown Obsessive and Compulsive Scale after 3 months

    3 months after treatment

Study Arms (2)

active tDCS

ACTIVE COMPARATOR

patients will received 2 sessions per day for 5 consecutive days. Each session will last 20 minutes. The tDCS device will deliver a direct current of 2mA during 20 minutes. Cathode will be localized in front of the left orbito-frontal on the FP3 point according to the EEG international reference. Anode will be localized in front of the right cerebellum 3 cm below the inion and 1 cm right from the midline

Device: transcranial dirrect current stimulation

SHAM tDCS

PLACEBO COMPARATOR

The same procedure will be applied except that the tDCS device will only deliver a current stimulation for the 10 first seconds.

Device: Sham tDCS

Interventions

transcranial dirrect current stimulationDEVICE

The tDCS device will deliver a direct current of 2mA during 20 minutes. Cathode will be localized in front of the left orbito-frontal on the FP3 point according to the EEG international reference. Anode will be localized in front of the right cerebellum 3 cm below the inion and 1 cm right from the midline

Also known as: tdcs
active tDCS
Sham tDCSDEVICE
SHAM tDCS

Eligibility Criteria

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

You may qualify if:

  • patients diagnosed with OCD according to DSM V criteria
  • YBOCS score of 16 and above, stable (\<20% of variation) during at least one month.
  • have received for at least 12 weeks of which 6 weeks was either at the maximum tolerated dose or alternatively the manufacturer's recommended maxi- mum daily dose.
  • age between 18 and 70
  • voluntary and competent to consent

You may not qualify if:

  • Major depressive disorder diagnosed with the DSM V criteria with a MADRS score \>30 (actual)
  • schizophrenia and other psychotic disorder
  • drugs or alcohol abuse
  • acutely suicidal
  • significant head injury, or of any neurosurgical procedure with implanted material
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Le Vinatier

Bron, 69500, France

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Bation Remy, MD

    CH le Vinatier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bation Remy, MD

CONTACT

33437915565remy.bation@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Rémy Bation

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 2, 2015

Study Start

March 12, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

May 8, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)