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

Sponsor

Nantes University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03758105

Collaborator

(none)

214

Enrollment

Locations

Arms

58.8

Anticipated Duration (Months)

17.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Depression	Other: tDCS associated with usual care Other: Usual care	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

214 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 4, 2019

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: 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.
Active Comparator: Usual care without tDCS (Arm B) Arm B patient receives usual care: medication management and psychotherapy.	Other: Usual care Medication and psychotherapy as prescribed in usual care

Arm

Intervention/Treatment

Experimental: 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.

Other: 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.

Active Comparator: Usual care without tDCS (Arm B)

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

Other: Usual care

Medication and psychotherapy as prescribed in usual care

Outcome Measures

Primary Outcome Measures

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

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
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.
Remission rate [12 months]
Remission rate is defined as follows: MADRS score < 10 (see detailed description of MADRS in outcome 3)
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)
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).
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.
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)
Adverse events linked to the medical treatment for depression [12 months]
Number and types of adverse events linked to the medical treatment for depression
Rate of suicide attempts [12 months]
number of suicide attempts per patient
Rate of suicides [12 months]
number of suicides
Treatment(s) switch(es) [At Baseline, one month, 2 months, 6 months and 12 months.]
Number of treatment switches 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
Treatments combination(s) [at Baseline, one month, 2 months, 6 months and 12 months.]
List of drugs (name) prescribed to the patient
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
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.
Total number of tDCS sessions [12 months]
total number of tDCS sessions per patient
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
Compliance with tDCS [12 months]
number of missed sessions over the number of planned sessions, per 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"
professional status [At baseline]
patient's professional status (active, unemployed, retired...)
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
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
5	CHU de Dijon	Dijon	France
6	Chu de Lyon	Lyon	France
7	Nantes University Hospital	Nantes	France	44100
8	Aphp Hopital Saint Antoine	Paris	France
9	CH Henri Laborit (Poitiers)	Poitiers	France
10	Centre hospitalier Guillaume Regnier Rennes	Rennes	France	35000
11	CH du Rouvray - Rouen	Rouen	France
12	CHU de Tours / CHRU de Tours	Tours	France