Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation
Recruiting · NCT06009523 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Hospitalier Henri Laborit
View the official record on ClinicalTrials.gov →Interventions studied
Transcranial direct current stimulation
What this trial is 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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed.
- Centre Hospitalier Nord-Deux-Sèvres - Faye-l'Abbesse, France
- Centre Hospitalier Henri Laborit - Poitiers, France