Clinical trial NCT03758105: Transcranial Direct Current Stimulation (tDCS) Cost-utility-analysis in Medical Care on Depressive Episode With One Drug Therapy Failure.
Official title: Transcranial Direct Current Stimulation (tDCS) Cost-utility-analysis in Medical Care on Depressive Episode With One Drug Therapy Failure.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Depression
psychiatry
health economics
Neurostimulation
tDCS
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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).

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cost-utility ratio, according to collective perspective of tDCS use in depression compared to usual care without active tDCS.
timeFrame: 12 months
Secondary outcomes:
measure: Budget impact analysis of spreading the most efficient strategy for using tDCS
timeFrame: 5 years
measure: Response rate
timeFrame: at baseline, at the end of each tDCS cure (for Arm A patients) through study completion (12 months) and at 12 months for all patients
measure: Remission rate
timeFrame: 12 months
measure: Relapse-free survival
timeFrame: 12 months
measure: MADRS score
timeFrame: At Baseline, one month, 2 months, 6 months and 12 months.
measure: Beck Depression Inventory (BDI) score
timeFrame: At Baseline, one month, 2 months, 6 months and 12 months.
measure: Clinical Global Impression (CGI) score
timeFrame: At Baseline, one month, 2 months, 6 months and 12 months.
measure: MOCA Score (Montreal Cognitive Assessment)
timeFrame: At Baseline, one month, 2 months, 6 months and 12 months.
measure: Adverse events linked to the medical treatment for depression
timeFrame: 12 months
measure: Rate of suicide attempts
timeFrame: 12 months
measure: Rate of suicides
timeFrame: 12 months
measure: Treatment(s) switch(es)
timeFrame: At Baseline, one month, 2 months, 6 months and 12 months.
measure: Treatment(s) dose increase
timeFrame: At Baseline, one month, 2 months, 6 months and 12 months.
measure: Treatments combination(s)
timeFrame: at Baseline, one month, 2 months, 6 months and 12 months.
measure: Declarative drug compliance via the MARS (Medication Adherence Report Scale)
timeFrame: at baseline and at 12 months
measure: Declarative drug compliance via the CRS (Clinician Rating Scale)
timeFrame: at baseline and at 12 months
measure: Total number of tDCS sessions
timeFrame: 12 months
measure: Number of days between the successive tDCS cures
timeFrame: 12 months
measure: Adverse events linked to tDCS
timeFrame: 12 months
measure: Compliance with tDCS
timeFrame: 12 months
measure: Patient acceptability of the tDCS technique: Analog Visual Scale
timeFrame: at the end of the first tDCS cure (up to one month)
measure: professional status
timeFrame: At baseline
measure: Impact of the implementation of the tDCS on the organization of care
timeFrame: 12 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Anglet
country: France
facility: Clinique Mirambeau
city: Besançon
country: France
facility: CHRU de Besançon
city: Clermont-Ferrand
country: France
facility: Chu Clermont Ferrand
city: Dijon
country: France
facility: CHU de Dijon
city: Lyon
country: France
facility: Chu de Lyon
city: Nantes
country: France
facility: Nantes University Hospital
city: Paris
country: France
facility: Aphp Hopital Saint Antoine
city: Poitiers
country: France
facility: CH Henri Laborit (Poitiers)
city: Rennes
country: France
facility: Centre hospitalier Guillaume Regnier Rennes
city: Rouen
country: France
facility: CH du Rouvray - Rouen
city: Tours
country: France
facility: CHU de Tours / CHRU de Tours
Study officials:
References:
citation: Sauvaget A, Lagalice L, Schirr-Bonnans S, Volteau C, Pere M, Dert C, Rivalland A, Tessier F, Lepage A, Tostivint A, Deschamps T, Thomas-Ollivier V, Robin A, Pineau N, Cabelguen C, Bukowski N, Guitteny M, Beslot A, Simons L, Network H, Vanelle JM, D'Urso G, Bulteau S, Riche VP; DISCO investigators group. Cost-utility analysis of transcranial direct current stimulation (tDCS) in non-treatment-resistant depression: the DISCO randomised controlled study protocol. BMJ Open. 2020 Jan 13;10(1):e033376. doi: 10.1136/bmjopen-2019-033376.