DepressionDISCONCT03758105
Transcranial Direct Current Stimulation (tDCS) Cost-utility-analysis in Medical Care on Depressive Episode With One Drug Therapy Failure.
A study of Depression, run by Nantes University Hospital at 12 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 12 sitesFrance
- Study dates
- 4 Feb 2019to 11 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
CHU d'Angers
Angers
Clinique Mirambeau
Anglet, 64600
CHRU de Besançon
Besançon
Chu Clermont Ferrand
Clermont-Ferrand, 63003
CHU de Dijon
Dijon
Chu de Lyon
Lyon
Nantes University Hospital
Nantes, 44100
Aphp Hopital Saint Antoine
Paris
CH Henri Laborit (Poitiers)
Poitiers
Centre hospitalier Guillaume Regnier Rennes
Rennes, 35000
CH du Rouvray - Rouen
Rouen
CHU de Tours / CHRU de Tours
Tours
About this study
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).
Read the 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.
- Conditions
- Depression
- Being tested
- tDCS associated with usual care, Usual care
- Keywords
- Depression, psychiatry, health economics, Neurostimulation, tDCS
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS associated with usual careOther
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 careOther
Medication and psychotherapy as prescribed in usual care
| Study group | Role | What they receive |
|---|---|---|
| Usual care and tDCS (Arm A) | Experimental | 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. Receives: Other: tDCS associated with usual care |
| Usual care without tDCS (Arm B) | Active comparator | Arm B patient receives usual care: medication management and psychotherapy. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (23)
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
Measured: 5 years
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.
Measured: 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
Remission rate
Remission rate is defined as follows: MADRS score < 10 (see detailed description of MADRS in outcome 3)
Measured: 12 months
Relapse-free survival
Number of patients with no relapse. Relapse is defined as follows: MADRS ≥ 20 (see detailed description of MADRS in outcome 3)
Measured: 12 months
MADRS score
MADRS score (see detailed description of MADRS in outcome 3)
Measured: At Baseline, one month, 2 months, 6 months and 12 months.
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).
Measured: At Baseline, one month, 2 months, 6 months and 12 months.
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.
Measured: At Baseline, one month, 2 months, 6 months and 12 months.
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)
Measured: At Baseline, one month, 2 months, 6 months and 12 months.
Adverse events linked to the medical treatment for depression
Number and types of adverse events linked to the medical treatment for depression
Measured: 12 months
Rate of suicide attempts
number of suicide attempts per patient
Measured: 12 months
Rate of suicides
number of suicides
Measured: 12 months
Treatment(s) switch(es)
Number of treatment switches per patient
Measured: At Baseline, one month, 2 months, 6 months and 12 months.
Treatment(s) dose increase
Number of drug(s) dose(s) increases prescribed to the patient
Measured: At Baseline, one month, 2 months, 6 months and 12 months.
Treatments combination(s)
List of drugs (name) prescribed to the patient
Measured: at Baseline, one month, 2 months, 6 months and 12 months.
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
Measured: at baseline and at 12 months
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.
Measured: at baseline and at 12 months
Total number of tDCS sessions
total number of tDCS sessions per patient
Measured: 12 months
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
Measured: 12 months
Adverse events linked to tDCS
Number and types of adverse events linked to the tDCS
Measured: 12 months
Compliance with tDCS
number of missed sessions over the number of planned sessions, per patient
Measured: 12 months
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"
Measured: at the end of the first tDCS cure (up to one month)
professional status
patient's professional status (active, unemployed, retired...)
Measured: At baseline
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start4 Feb 2019
- Primary completion11 Nov 2023 (estimated)
- Study completion11 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758105
- Sponsor's protocol ID
- RC17_0493
- Acronym
- DISCO
- Status last verified
- Feb 2023
- First submitted
- 23 Nov 2018
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31937653
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) Cost-utility-analysis in Medical Care on Depressive Episode With One Drug Therapy Failure.
- ClinicalTrials.gov ID
- NCT03758105
- Acronym / sponsor ID
- DISCO / RC17_0493
- Conditions
- Depression
- Keywords
- Depression, psychiatry, health economics, Neurostimulation, tDCS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 11 Nov 2023 (estimated)
- Study completion
- 11 Nov 2023 (estimated)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care and tDCS (Arm A) | Experimental | Other: tDCS associated with usual careArm 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) | Active comparator | Other: Usual careArm B patient receives usual care: medication management and psychotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS associated with usual careA 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. | Other | Usual care and tDCS (Arm A) |
| Usual careMedication and psychotherapy as prescribed in usual care | Other | Usual care without tDCS (Arm B) |
Primary outcome
Cost-utility ratio, according to collective perspective of tDCS use in depression compared to usual care without active tDCS.
Time frame: 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.
23 secondary outcomes
Budget impact analysis of spreading the most efficient strategy for using tDCS
Time frame: 5 years
Response rate
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
Remission rate
Time frame: 12 months
Relapse-free survival
Time frame: 12 months
MADRS score
Time frame: At Baseline, one month, 2 months, 6 months and 12 months.
Beck Depression Inventory (BDI) score
Time frame: At Baseline, one month, 2 months, 6 months and 12 months.
Clinical Global Impression (CGI) score
Time frame: At Baseline, one month, 2 months, 6 months and 12 months.
MOCA Score (Montreal Cognitive Assessment)
Time frame: At Baseline, one month, 2 months, 6 months and 12 months.
Adverse events linked to the medical treatment for depression
Time frame: 12 months
Rate of suicide attempts
Time frame: 12 months
Rate of suicides
Time frame: 12 months
Treatment(s) switch(es)
Time frame: At Baseline, one month, 2 months, 6 months and 12 months.
Treatment(s) dose increase
Time frame: At Baseline, one month, 2 months, 6 months and 12 months.
Treatments combination(s)
Time frame: at Baseline, one month, 2 months, 6 months and 12 months.
Declarative drug compliance via the MARS (Medication Adherence Report Scale)
Time frame: at baseline and at 12 months
Declarative drug compliance via the CRS (Clinician Rating Scale)
Time frame: at baseline and at 12 months
Total number of tDCS sessions
Time frame: 12 months
Number of days between the successive tDCS cures
Time frame: 12 months
Adverse events linked to tDCS
Time frame: 12 months
Compliance with tDCS
Time frame: 12 months
Patient acceptability of the tDCS technique: Analog Visual Scale
Time frame: at the end of the first tDCS cure (up to one month)
professional status
Time frame: At baseline
Impact of the implementation of the tDCS on the organization of care
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Derived from this study: PubMed 31937653Sauvaget 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Depression, run by Nantes University Hospital at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-utility ratio, according to collective perspective of tDCS use in depression compared to usual care without active tDCS. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03758105, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023; AzTrials last refreshed its copy on 1 Nov 2026.