RecruitingNot ApplicableNCT06009523
Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation
Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation in Treatment-resistant Depression : a Pilot Study
Sponsor
Centre Hospitalier Henri Laborit
Enrollment
50 participants
Start Date
Oct 26, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria8
- 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 Criteria7
- 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
Interventions
DEVICETranscranial direct current stimulation
1 stimulation per day during 15 days.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06009523