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

Not Applicable

Active, not recruiting

• Conditions: Depression
• Interventions: Other: tDCS associated with usual care; Other: Usual care

• Registration Number: NCT03758105
• Lead Sponsor: Nantes University Hospital

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.

Study Timeline

• Study First Submitted: 2018-11-23
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-29
• Study Start: 2019-02-04
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-24
• Last Update Posted: 2023-02-27
• Primary Completion: 2023-11-11
• Study Completion: 2023-11-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 214

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care and tDCS (Arm A)	tDCS associated with usual care	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.
Usual care without tDCS (Arm B)	Usual care	Arm B patient receives usual care: medication management and psychotherapy.

Primary Outcome Measures

Name	Time	Method
Cost-utility ratio, according to collective perspective of tDCS use in depression compared to usual care without active tDCS.	12 months	The utility will be measured by : Quality Adjusted Life Year (QALYs) as estimated from responses to the Euroqol-5 Dimensions (EQ-5D) health-related quality of life questionnaire. The questionnaire focuses on 5 dimensions: mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression. For each of these dimensions, 5 answers are possible.; The costs will be measured by the addition of the following costs: Drugs dispensing via Health insurance database "National system of information of the French health insurance" (SNIIRAM), hospitalizations, work stoppages and care consumption collected in a declarative patient questionnaire.

Secondary Outcome Measures

Name	Time	Method
Compliance with tDCS	12 months	number of missed sessions over the number of planned sessions, per patient
Budget impact analysis of spreading the most efficient strategy for using tDCS	5 years	Comparison of intervention costs on the study sample and projection of these costs over 5 years, from the health insurance and hospital perspectives
Rate of suicides	12 months	number of suicides
Declarative drug compliance via the MARS (Medication Adherence Report Scale)	at baseline and at 12 months	MARS is the Medication Adherence Report Scale, including 10 questions, the global score ranges from 0 to 10, 0 corresponds to the worst drug compliance and 10 to an excellent drug compliance
Impact of the implementation of the tDCS on the organization of care	12 months	The organizational impact of the tDCS will be evaluated from the point of view of doctors, nurse and patients: staff, equipment, maintenance, location and mobilization time of these resources, using a specific questionnaire
Response rate	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	Response is defined as follows: decrease of the MADRS score by at least 50% compared to baseline score. MADRS stands for Montgomery-Asberg Depression Rating Scale. It is used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. A score from 0 to 6 being normal/symptom absent and a score \>34 being severe depression.
Total number of tDCS sessions	12 months	total number of tDCS sessions per patient
Relapse-free survival	12 months	Number of patients with no relapse. Relapse is defined as follows: MADRS ≥ 20 (see detailed description of MADRS in outcome 3)
MOCA Score (Montreal Cognitive Assessment)	At Baseline, one month, 2 months, 6 months and 12 months.	Thirty items assessing multiple cognitive domains are contained in the MoCA: short-term memory (5 points); visuospatial abilities via clock drawing (3 points), and a cube copy task (1 point); executive functioning via an adaptation of Trail Making Test Part B (1 point), phonemic fluency (1 point), and verbal abstraction (2 points); attention, concentration, and working memory via target detection (1 point), serial subtraction (3 points), digits forward (1 point), and digits backward (1 point); language via confrontation naming with low-familiarity animals (3 points), and repetition of complex sentences (2 points); and orientation to time and place (6 points)
Rate of suicide attempts	12 months	number of suicide attempts per patient
Treatment(s) dose increase	At Baseline, one month, 2 months, 6 months and 12 months.	Number of drug(s) dose(s) increases prescribed to the patient
Declarative drug compliance via the CRS (Clinician Rating Scale)	at baseline and at 12 months	CRS is the Clinician Rating Scale , including 7 questions, the global score ranges from 1 to 7, 7 being the worst level of drug compliance.
Number of days between the successive tDCS cures	12 months	Number of days between end of tDCS cure X and beginning of cure X+1, for each patient
Adverse events linked to tDCS	12 months	Number and types of adverse events linked to the tDCS
Remission rate	12 months	Remission rate is defined as follows: MADRS score \< 10 (see detailed description of MADRS in outcome 3)
MADRS score	At Baseline, one month, 2 months, 6 months and 12 months.	MADRS score (see detailed description of MADRS in outcome 3)
Beck Depression Inventory (BDI) score	At Baseline, one month, 2 months, 6 months and 12 months.	The BDI is 13-item multiple-choice self-report inventory, for measuring the severity of depression. The global score is an addition of each item's score and ranges from 0 (minimal depression) to 39 (severe depression).
Treatment(s) switch(es)	At Baseline, one month, 2 months, 6 months and 12 months.	Number of treatment switches per patient
professional status	At baseline	patient's professional status (active, unemployed, retired...)
Clinical Global Impression (CGI) score	At Baseline, one month, 2 months, 6 months and 12 months.	The Clinical Global Impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. Each scale is rated from 0 to 7. 0 being the best level and 7 the worst level.
Adverse events linked to the medical treatment for depression	12 months	Number and types of adverse events linked to the medical treatment for depression
Treatments combination(s)	at Baseline, one month, 2 months, 6 months and 12 months.	List of drugs (name) prescribed to the patient
Patient acceptability of the tDCS technique: Analog Visual Scale	at the end of the first tDCS cure (up to one month)	Analog Visual Scale of acceptability of the tDCS completed by the patient, ranging from 0 to 10. 0 being "not acceptable" and 10 being "totally acceptable"

Trial Locations

Locations (12)

CHU d'Angers; 🇫🇷 Angers, France

Clinique Mirambeau; 🇫🇷 Anglet, France

CHRU de Besançon; 🇫🇷 Besançon, France

Chu de Lyon; 🇫🇷 Lyon, France

Chu Clermont Ferrand; 🇫🇷 Clermont-Ferrand, France

Nantes University Hospital; 🇫🇷 Nantes, France

CHU de Dijon; 🇫🇷 Dijon, France

CH Henri Laborit (Poitiers); 🇫🇷 Poitiers, France

Aphp Hopital Saint Antoine; 🇫🇷 Paris, France

CH du Rouvray - Rouen; 🇫🇷 Rouen, France

Centre hospitalier Guillaume Regnier Rennes; 🇫🇷 Rennes, France

CHU de Tours / CHRU de Tours; 🇫🇷 Tours, France