Clinical Trials in France / NCT06009523
Recruiting
Not applicable
Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation
NCT06009523 · tracked via the Priya Life Science France tracker
Condition(s) studied
Depression and Suicide
Investigational drug(s) / intervention(s)
Transcranial direct current stimulation
Transcranial direct current stimulation: 1 stimulation per day during 15 days.
Study summary
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
Eligibility
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
Primary outcome measure(s)
- Change from Baseline in suicidal ideation on the Scale for Suicide Ideation (SSI) at "Day 19" — Baseline and "Day 19"
The main judgment criterion is the evolution of suicidal ideation which is evaluated by the Beck Scale for Suicide Ideation (SSI) between Baseline and "Day 19"
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Centre Hospitalier Nord-Deux-Sèvres | Faye-l'Abbesse | France | Recruiting |
| Centre Hospitalier Henri Laborit | Poitiers | France | Recruiting |
More Centre Hospitalier Henri Laborit trials in France
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06009523 on ClinicalTrials.gov ↗ ← All trials in France