Transcranial Direct Current Stimulation (tDCS) Cost-utility-analysis in Medical Care on Depressive Episode With One Drug Therapy Failure. (DISCO)

Nantes University Hospital (NUH)

Status: Active, not recruiting

Conditions: Depression

Treatments: Other: tDCS associated with usual care; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT03758105

RC17_0493

Details and patient eligibility

About

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 period involving patients with 1 or 2 depression treatment(s) failed.

Eligible subject will be randomized in 2 groups, usual care with tDCS cure (arm A) or only usual care (arm B).

Full 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 following during 12 months. Patients are randomized in 2 arms. Arm A usual care with tDCS cure or arm B usual care without tDCS.

Patient in arm A get a initial tDCS cure one week after randomization. If these patients are answering to the treatment, they can have a new cure in case of relapse. This new cure can start from the second month following initial treatment.

Enrollment: 214 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

214 participants in 2 patient groups

Usual care and tDCS (Arm A)

Experimental group

Description:

Arm A patient receives a first tDCS treatment in association with usual care (medication, psychotherapy...). If the patient is responding to tDCS, he can have other tDCS treatments in case of relapse.

Treatment:

Other: tDCS associated with usual care

Usual care without tDCS (Arm B)

Active Comparator group

Description:

Arm B patient receives usual care: medication management and psychotherapy.

Treatment:

Other: Usual care