How to Reduce Suicidal Thoughts and Impulsivity in Depression (DEPIMPULSE)

Centre Hospitalier Universitaire de Besancon

Status: Enrolling

Conditions: Suicidal Ideation; Impulsive Behavior; Unipolar Depression

Treatments: Device: active tDCS stimulating right OFC; Device: active tDCS stimulating left DLPFC; Device: sham tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT05894980

2022/724

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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"

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 3 patient groups

active tDCS on left DLPFC

Experimental group

Description:

Active tDCS applied on left dorsolateral prefrontal cortex \[DLPFC\]

Treatment:

Device: active tDCS stimulating left DLPFC

active tDCS on right OFC

Active Comparator group

Description:

Active tDCS applied on right orbitofrontal cortex \[OFC\]

Treatment:

Device: active tDCS stimulating right OFC

sham tDCS

Sham Comparator group

Description:

Sham tDCS applied on left dorsolateral prefrontal cortex \[DLPFC\]

Treatment:

Device: sham tDCS