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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-04

Study Completion Date

2023-11-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Transcranial Direct Current Stimulation (tDCS) as add-on Treatment for Resistant Major Depression

NCT01428804

Resistant Major Depression

COMPLETED PHASE2

Deep Brain Stimulation of Nucleus Accumbens for Chronic and Resistant Major Depressive Disorder

NCT01569711

Major Depressive Disorder, Recurrent, Unspecified

COMPLETED

Transcranial Direct Current Stimulation in a Home Treatment Setting for Major Depression

NCT05172505

Depression

UNKNOWN NA

Cost-utility Analysis of Maintenance rTMS for Treatment-resistant Depression

NCT03701724

Treatment-resistant Depression

UNKNOWN NA

Comparison of Anodal Transcranial Direct Current Stimulation (t-DCS) and Sham Stimulation in Patients With Treatment-resistant Depression

NCT02141776

Major Depressive Disorder

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Usual care and tDCS (Arm A)

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.

Group Type EXPERIMENTAL

tDCS associated with usual care

Intervention Type OTHER

A tDCS cure will be given to the group "tDCS", one week after their randomization.

This will be done in association with usual care: medication and psychotherapy Parameters: Anodal stimulation on dorso-lateral prefrontal cortex left, 2mA current.

Treatment will consist of 15 days with 30 minutes stimulation per day, 5 days a week for 3 weeks.

Usual care without tDCS (Arm B)

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

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Medication and psychotherapy as prescribed in usual care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tDCS associated with usual care

A tDCS cure will be given to the group "tDCS", one week after their randomization.

This will be done in association with usual care: medication and psychotherapy Parameters: Anodal stimulation on dorso-lateral prefrontal cortex left, 2mA current.

Treatment will consist of 15 days with 30 minutes stimulation per day, 5 days a week for 3 weeks.

Intervention Type OTHER

Usual care

Medication and psychotherapy as prescribed in usual care

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No