Clinical trial NCT05894980: How to Reduce Suicidal Thoughts and Impulsivity in Depression
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Unipolar Depression
Impulsive Behavior
Suicidal Ideation
Keywords: transcranial stimulation
tDCS
left PreFrontalDorsoLateral Cortex
right OrbitoFrontal Cortex
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Fondation FondaMental
First posted: 2023-06-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Depressive disorders are one of the most frequent pathologies in psychiatry. The lifetime prevalence of the characterized depressive episode is indeed particularly high, between 16.6% in the United States and 24.1% in France. Because of this high prevalence, and because they constitute a pathology with a high risk of suicidal behavior (SC), depressive disorders are a major target of medical strategies for suicide prevention. In addition to suicidal ideation, impulsivity, considered as the tendency to express spontaneous, excessive and/or unplanned behaviors, is recognized as being a major factor precipitating SCs.

With a pilot, prospective, multicenter design, the perspectives of DEPIMPULSE include being able to develop an innovative therapeutic approach in the reduction of risky behaviors, in particular suicidal ideation, associated impulsivity, suicidal risk in patients suffering from depression, while improving our understanding of the behavioral aspects and associated cognitions.

The treatment will be delivered during 5 consecutive days (D1 to D5).

Baseline measures (D0) will be compared to those obtained after the treatment administration (last day of treatment (D5) and 2 weeks (+W2) and 1 month (+W4) after the end of treatment.

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"

Primary outcomes:
measure: BSS scores
timeFrame: Baseline (Day 0), Day 5 (D5)
Secondary outcomes:
measure: BSS scores
timeFrame: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
measure: C-SSRS scores
timeFrame: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
measure: BIS-10 scores
timeFrame: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
measure: UPPS scores
timeFrame: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
measure: BART scores
timeFrame: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
measure: Cognitive assessment
timeFrame: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
measure: Delay discounting with MCQ scores
timeFrame: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
measure: Severity of depressive symptoms evaluated by the clinician
timeFrame: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
measure: Severity of depressive symptoms evaluated by the patient
timeFrame: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
measure: Quality of life measured with the EQ-5D-5L
timeFrame: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
measure: Psychological and Physical Pain-Visual Analogic Scale (PPP-VAS)
timeFrame: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Créteil
country: France
facility: Hôpital Chenevier, GH Henri Mondor
city: Montpellier
country: France
facility: CHU de Montpellier
Study officials:
affiliation: CHU de Besançon
name: Djamila BENNABI, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: