Status:
UNKNOWN
Transcranial Direct Current Stimulation (tDCS) Cost-utility-analysis in Medical Care on Depressive Episode With One Drug Therapy Failure.
Lead Sponsor:
Nantes University Hospital
Conditions:
Depression
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine the transcranial direct current stimulation (tDCS) cost-utility in the depression therapy. This is a 3 years medico-economics study with 1 year follow-up per...
Detailed Description
Transcranial direct current stimulation is a non-invasive brain neuromodulation technique. tDCS can be a new therapy in depression. This study focuses on tDCS cost-utility-analysis. Each patient is f...
Eligibility Criteria
Inclusion
- Depression according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) with 1 or 2 failed antidepressant treatments for the current episode.
- MADRS score superior or equal to 15.
- Patient agreeing to participate in the study
- Patient able to answer questionnaires and able to go at research center for follow-up visit.
- Patient with social insurance
Exclusion
- Electroconvulsive therapy or repetitive transcranial magnetic stimulation for current depressive episode.
- Depressive episode with psychotic symptoms or mixed.
- Schizophrenia or addiction to another substance than nicotine
- Severe neurological disorder (like epilepsy, neurological affect, neurological disease)
- Severe and / or progressive somatic pathology (leave to the investigator judgment) preventing from participation in the study.
- tDCS specific contraindications (intracerebral metallic implant, pacemaker)
- Pregnancy or breast feeding.
- Woman of childbearing age without contraception (hormonal or with medical device).
- Participation in another interventional clinical trial
- legal protection
- Persons incarcerated or in obligation of treatment / medical treatment order.
Key Trial Info
Start Date :
February 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2023
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT03758105
Start Date
February 4 2019
End Date
November 11 2023
Last Update
February 27 2023
Active Locations (12)
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1
CHU d'Angers
Angers, France
2
Clinique Mirambeau
Anglet, France, 64600
3
CHRU de Besançon
Besançon, France
4
Chu Clermont Ferrand
Clermont-Ferrand, France, 63003