RecruitingNot ApplicableNCT05894980

How to Reduce Suicidal Thoughts and Impulsivity in Depression

Controlled Randomized Non-comparative Trial Assessing Active Transcranial Direct Current Stimulation [tDCS] on Left Dorsoleteral Prefrontal Cortex Versus Active tDCS Active on Right Orbitofrontal Cortex to Treat Unipolar Depression


Sponsor

Centre Hospitalier Universitaire de Besancon

Enrollment

100 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The study aims at investigating if tDCS applied to left DLPFC or to right OFC to treatment as usual is effective in reducing severe suicidal ideas in major depressive episode.


Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • Man or woman older than 18 years oldRight-handed
  • Signed Informed Consent form
  • Subject affiliated to or beneficiary from a French social security regime
  • Inpatient or outpatient at the Adult Psychiatry Service
  • Diagnosis of Major Depressive Disorder according to the 5th edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria and confirmation by the MINI Structured Clinical Interview
  • MADRS score ≥ 18
  • Beck Scale for Suicide Ideation (BSS) score ≥8
  • Under antidepressant treatment
  • Absence of severe progressive neurologic and/or somatic pathologies (specially tumors, degenerative diseases)

Exclusion Criteria12

  • tDCS contraindication
  • Younger than 18 years old
  • Left-handed
  • under mood stabilizer and/or antiepileptic
  • treated by ECT or rTMS or tDCS for the current eposide
  • Subject under measure of protection or guardianship of justice
  • Presence of other psychiatric pahtologies
  • Subject beneficiary from a legal protection regime
  • Subject unlikely to cooperate or low cooperation stated by investigator
  • Subject not covered by social security
  • Pregnant woman
  • Subject being in the exclusion period of another study or provided for by the "National Volunteer File"

Interventions

DEVICEactive tDCS stimulating left DLPFC

20 active tDCS sessions (4 sessions/day for 5 days, 30 min each, 2 mA) applied to the left DLPFC

DEVICEactive tDCS stimulating right OFC

20 active tDCS sessions (4 sessions/day for 5 days, 30 min each, 2 mA) applied to the right OFC

DEVICEsham tDCS

20 active tDCS sessions (4 sessions/day for 5 days, 30 min each, 0 mA) applied to the left DLPFC


Locations(4)

CHU de Besançon

Besançon, France

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Hôpital Chenevier, GH Henri Mondor

Créteil, France

CHU de Montpellier

Montpellier, France

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NCT05894980


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