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

Primary Purpose

Depression

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
tDCS associated with usual care
Usual care
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, psychiatry, health economics, Neurostimulation, tDCS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • CHU d'Angers
  • Clinique Mirambeau
  • CHRU de Besançon
  • Chu Clermont Ferrand
  • CHU de Dijon
  • Chu de Lyon
  • Nantes University Hospital
  • Aphp Hopital Saint Antoine
  • CH Henri Laborit (Poitiers)
  • Centre hospitalier Guillaume Regnier Rennes
  • CH du Rouvray - Rouen
  • CHU de Tours / CHRU de Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Usual care and tDCS (Arm A)

Usual care without tDCS (Arm B)

Arm 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.

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

Outcomes

Primary Outcome Measures

Cost-utility ratio, according to collective perspective of tDCS use in depression compared to usual care without active tDCS.
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
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
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
Remission rate is defined as follows: MADRS score < 10 (see detailed description of MADRS in outcome 3)
Relapse-free survival
Number of patients with no relapse. Relapse is defined as follows: MADRS ≥ 20 (see detailed description of MADRS in outcome 3)
MADRS score
MADRS score (see detailed description of MADRS in outcome 3)
Beck Depression Inventory (BDI) score
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
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)
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
Number and types of adverse events linked to the medical treatment for depression
Rate of suicide attempts
number of suicide attempts per patient
Rate of suicides
number of suicides
Treatment(s) switch(es)
Number of treatment switches per patient
Treatment(s) dose increase
Number of drug(s) dose(s) increases prescribed to the patient
Treatments combination(s)
List of drugs (name) prescribed to the patient
Declarative drug compliance via the MARS (Medication Adherence Report Scale)
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)
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
total number of tDCS sessions per patient
Number of days between the successive tDCS cures
Number of days between end of tDCS cure X and beginning of cure X+1, for each patient
Adverse events linked to tDCS
Number and types of adverse events linked to the tDCS
Compliance with tDCS
number of missed sessions over the number of planned sessions, per patient
Patient acceptability of the tDCS technique: Analog Visual Scale
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
patient's professional status (active, unemployed, retired...)
Impact of the implementation of the tDCS on the organization of care
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

Full Information

First Posted
November 23, 2018
Last Updated
February 24, 2023
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03758105
Brief Title
Transcranial Direct Current Stimulation (tDCS) Cost-utility-analysis in Medical Care on Depressive Episode With One Drug Therapy Failure.
Acronym
DISCO
Official Title
Transcranial Direct Current Stimulation (tDCS) Cost-utility-analysis in Medical Care on Depressive Episode With One Drug Therapy Failure.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 4, 2019 (Actual)
Primary Completion Date
November 11, 2023 (Anticipated)
Study Completion Date
November 11, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, psychiatry, health economics, Neurostimulation, tDCS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care and tDCS (Arm A)
Arm Type
Experimental
Arm 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.
Arm Title
Usual care without tDCS (Arm B)
Arm Type
Active Comparator
Arm Description
Arm B patient receives usual care: medication management and psychotherapy.
Intervention Type
Other
Intervention Name(s)
tDCS associated with usual care
Intervention Description
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
Intervention Name(s)
Usual care
Intervention Description
Medication and psychotherapy as prescribed in usual care
Primary Outcome Measure Information:
Title
Cost-utility ratio, according to collective perspective of tDCS use in depression compared to usual care without active tDCS.
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Budget impact analysis of spreading the most efficient strategy for using tDCS
Description
Comparison of intervention costs on the study sample and projection of these costs over 5 years, from the health insurance and hospital perspectives
Time Frame
5 years
Title
Response rate
Description
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.
Time Frame
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
Title
Remission rate
Description
Remission rate is defined as follows: MADRS score < 10 (see detailed description of MADRS in outcome 3)
Time Frame
12 months
Title
Relapse-free survival
Description
Number of patients with no relapse. Relapse is defined as follows: MADRS ≥ 20 (see detailed description of MADRS in outcome 3)
Time Frame
12 months
Title
MADRS score
Description
MADRS score (see detailed description of MADRS in outcome 3)
Time Frame
At Baseline, one month, 2 months, 6 months and 12 months.
Title
Beck Depression Inventory (BDI) score
Description
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).
Time Frame
At Baseline, one month, 2 months, 6 months and 12 months.
Title
Clinical Global Impression (CGI) score
Description
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.
Time Frame
At Baseline, one month, 2 months, 6 months and 12 months.
Title
MOCA Score (Montreal Cognitive Assessment)
Description
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)
Time Frame
At Baseline, one month, 2 months, 6 months and 12 months.
Title
Adverse events linked to the medical treatment for depression
Description
Number and types of adverse events linked to the medical treatment for depression
Time Frame
12 months
Title
Rate of suicide attempts
Description
number of suicide attempts per patient
Time Frame
12 months
Title
Rate of suicides
Description
number of suicides
Time Frame
12 months
Title
Treatment(s) switch(es)
Description
Number of treatment switches per patient
Time Frame
At Baseline, one month, 2 months, 6 months and 12 months.
Title
Treatment(s) dose increase
Description
Number of drug(s) dose(s) increases prescribed to the patient
Time Frame
At Baseline, one month, 2 months, 6 months and 12 months.
Title
Treatments combination(s)
Description
List of drugs (name) prescribed to the patient
Time Frame
at Baseline, one month, 2 months, 6 months and 12 months.
Title
Declarative drug compliance via the MARS (Medication Adherence Report Scale)
Description
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
Time Frame
at baseline and at 12 months
Title
Declarative drug compliance via the CRS (Clinician Rating Scale)
Description
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.
Time Frame
at baseline and at 12 months
Title
Total number of tDCS sessions
Description
total number of tDCS sessions per patient
Time Frame
12 months
Title
Number of days between the successive tDCS cures
Description
Number of days between end of tDCS cure X and beginning of cure X+1, for each patient
Time Frame
12 months
Title
Adverse events linked to tDCS
Description
Number and types of adverse events linked to the tDCS
Time Frame
12 months
Title
Compliance with tDCS
Description
number of missed sessions over the number of planned sessions, per patient
Time Frame
12 months
Title
Patient acceptability of the tDCS technique: Analog Visual Scale
Description
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"
Time Frame
at the end of the first tDCS cure (up to one month)
Title
professional status
Description
patient's professional status (active, unemployed, retired...)
Time Frame
At baseline
Title
Impact of the implementation of the tDCS on the organization of care
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
CHU d'Angers
City
Angers
Country
France
Facility Name
Clinique Mirambeau
City
Anglet
ZIP/Postal Code
64600
Country
France
Facility Name
CHRU de Besançon
City
Besançon
Country
France
Facility Name
Chu Clermont Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
CHU de Dijon
City
Dijon
Country
France
Facility Name
Chu de Lyon
City
Lyon
Country
France
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44100
Country
France
Facility Name
Aphp Hopital Saint Antoine
City
Paris
Country
France
Facility Name
CH Henri Laborit (Poitiers)
City
Poitiers
Country
France
Facility Name
Centre hospitalier Guillaume Regnier Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
CH du Rouvray - Rouen
City
Rouen
Country
France
Facility Name
CHU de Tours / CHRU de Tours
City
Tours
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
31937653
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.
Results Reference
derived

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

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