Status:
RECRUITING
Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation
Lead Sponsor:
Centre Hospitalier Henri Laborit
Conditions:
Depression and Suicide
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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
Detailed 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 eli...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06009523
Start Date
October 26 2023
End Date
December 1 2027
Last Update
June 5 2025
Active Locations (2)
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1
Centre Hospitalier Nord-Deux-Sèvres
Faye-l'Abbesse, France
2
Centre Hospitalier Henri Laborit
Poitiers, France