Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation (tDCS-IDSDEP)

Centre Hospitalier Henri Laborit

Status: Enrolling

Conditions: Depression and Suicide

Treatments: Device: Transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06009523

2022-A01454-39

Details and patient eligibility

About

The main objective of this study is to demonstrate that 15 transcranial direct current stimulation (tDCS) sessions of 30 minutes at 2 mA intensity are effective to reduce suicidal ideation

Full description

After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening visit to determine eligibility for study entry. Patient who meet the eligibility requirements be able to start the 15 tDCS sessions at the rate of one session per day. After the last session, patients will perform three follow-up visits on D19, D49 and D79

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 18 years
• Written informed consent
• Diagnosis of recurrent or isolated depressive episode according to DSM IV criteria (A.P.A. 1994).
• Stable antidepressant treatment for 3 weeks
• MADRS score ≥ 20
• SSI score > 3
• Subject affiliated to a health insurance system
• Woman with effective contraception and agreeing to maintain it throughout the study period.

Exclusion criteria

• Depression with psychotic features Axis I (DSM IV) co-morbid diagnosis of schizophrenia, alcohol and/or other substance dependence (or abuse) (lifetime)
• Patient who has already undergone an electroconvulsive therapy course for the current episode and does not respond to this treatment
• Patient deprived of liberty
• Patient with high suicide risk (item 10 MADRS > 4) in the absence of hospitalization
• Contraindication to tDCS: intracerebral metallic implant (with the exception of dental implants), cardiac pacemaker, active or non-implanted devices in the region of the head, acute eczema in the planned stimulation area
• Pregnant, parturient or breastfeeding woman
• Simultaneous participation in another interventional research

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Active tDCS

Experimental group

Description:

Participants received an active tdcs: transcranial direct current with an intensity of 2 mA for 30 minutes

Treatment:

Device: Transcranial direct current stimulation