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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-26

Study Completion Date

2027-12-01

Brief Summary

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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

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Detailed Description

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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

Conditions

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Depression and Suicide

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active tDCS

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

Group Type EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type DEVICE

1 stimulation per day during 15 days.

Interventions

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Transcranial direct current stimulation

1 stimulation per day during 15 days.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No