Reducing 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

This study is testing if a new brain stimulation treatment can help people with major depression feel less suicidal and reduce impulsive thoughts.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Besancon (other)
• Locations: 4 sites (Besançon and 3 other locations)
• Trial ID: NCT05894980 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex (DLPFC) and the right orbitofrontal cortex (OFC) in reducing severe suicidal ideation in patients with major depressive disorder. Conducted as a pilot, prospective, multicenter trial, it aims to develop innovative therapeutic approaches for managing impulsivity and suicidal risk associated with depression. Participants will receive treatment over five consecutive days, with assessments conducted at baseline, immediately after treatment, and at two and four weeks post-treatment to evaluate changes in suicidal thoughts and impulsivity.

Who should consider this trial

Good fit: Ideal candidates are right-handed adults over 18 years old diagnosed with major depressive disorder and experiencing significant suicidal ideation.

Not a fit: Patients who are left-handed, under mood stabilizers or antiepileptic medications, or have other psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce suicidal thoughts and impulsivity in patients suffering from major depressive disorder.

How similar studies have performed: While the use of tDCS in treating depression is being explored, this specific approach targeting impulsivity and suicidal ideation is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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"

Where this trial is running

Besançon and 3 other locations

• CHU de Besançon — Besançon, France (RECRUITING)
• CHU de Clermont-Ferrand — Clermont-Ferrand, France (RECRUITING)
• Hôpital Chenevier, GH Henri Mondor — Créteil, France (NOT_YET_RECRUITING)
• CHU de Montpellier — Montpellier, France (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Djamila BENNABI, MD PhD — CHU de Besançon
• Study coordinator: Djamila BENNABI, MD PhD

Conditions: Unipolar Depression, Impulsive Behavior, Suicidal Ideation, transcranial stimulation, tDCS, left PreFrontalDorsoLateral Cortex, right OrbitoFrontal Cortex