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Completed

NCT Number: NCT03304600

tDCS for Treatment Resistant Obsessive Compulsive Disorder

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.

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils De Lyon, Lyon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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),
  • 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

Treatment and study plan

Active stimulation

Device

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

Sham stimulation

Device

Patients will receive a Sham stimulation during 30 mn

Primary outcomes

  1. 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

  1. Yale Brown Obsessive Compulsive Scale (YBOCS)

    Time frame: Month 1

    i. Change from baseline to month 1 in Yale Brown Obsessive Compulsive Scale (YBOCS) scores, between treatment groups.

  2. Yale Brown Obsessive Compulsive Scale (YBOCS),

    Time frame: Month 3

    ii. Response rate at month 3 in Yale Brown Obsessive Compulsive Scale (YBOCS) score from baseline, between treatment groups.

  3. Clinical Global Impression (CGI)

    Time frame: Month 1

    Change from baseline to month 1 in above scales between treatment groups;

  4. Clinical Global Impression (CGI)

    Time frame: Month 3

    Change from baseline to month 3 in above scales between treatment groups;

  5. Brown Assessment of Beliefs Scale (BABS)

    Time frame: Month 1

    Change from baseline to month 1 in above scales between treatment groups;

  6. Brown Assessment of Beliefs Scale (BABS)

    Time frame: Month 3

    Change from baseline to month 3 in above scales between treatment groups;

  7. Brief Anxiety Scale (BAS)

    Time frame: Month 1

    Change from baseline to month 1 in above scales between treatment groups;

  8. Brief Anxiety Scale (BAS)

    Time frame: Month 3

    Change from baseline to month 3 in above scales between treatment groups;

  9. Montgomery and Asberg Depression Rating Scale (MADRS)

    Time frame: Month 1

    Change from baseline to month 1 in above scales between treatment groups;

  10. Montgomery and Asberg Depression Rating Scale (MADRS)

    Time frame: Month 3

    Change from baseline to month 3 in above scales between treatment groups;

  11. Hospital Anxiety and Depression scale (HAD)

    Time frame: Month 1

    Change from baseline to month 1 in above scales between treatment groups;

  12. Hospital Anxiety and Depression scale (HAD)

    Time frame: Month 3

    Change from baseline to month 3 in above scales between treatment groups;

  13. Sheehan Disability Scale, (SDS)

    Time frame: Month 1

    Change from baseline to month 1 in above scales between treatment groups;

  14. Sheehan Disability Scale, (SDS)

    Time frame: Month 3

    Change from baseline to month 3 in above scales between treatment groups;

Other outcomes

  1. Number of adverse events

    Time frame: 3 Month

    Safety of the tDCS treatment :

    • assessed by physical examination during each tDCS session
    • any other adverse events (AEs)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Henri Laborit

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: tDCS-TOC

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Oct 9, 2017
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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