Transcranial Direct Current Stimulation (tDCS) Cost-utility-analysis in Medical Care on Depressive Episode With One Drug Therapy Failure. (DISCO)
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|ClinicalTrials.gov Identifier: NCT03758105|
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : January 20, 2021
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||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||214 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||February 4, 2019|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2023|
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
- 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.
- Budget impact analysis of spreading the most efficient strategy for using tDCS [ Time Frame: 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 [ 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 ]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 [ Time Frame: 12 months ]Remission rate is defined as follows: MADRS score < 10 (see detailed description of MADRS in outcome 3)
- Relapse-free survival [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 12 months ]Number and types of adverse events linked to the medical treatment for depression
- Rate of suicide attempts [ Time Frame: 12 months ]number of suicide attempts per patient
- Rate of suicides [ Time Frame: 12 months ]number of suicides
- Treatment(s) switch(es) [ Time Frame: At Baseline, one month, 2 months, 6 months and 12 months. ]Number of treatment switches per patient
- Treatment(s) dose increase [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 12 months ]total number of tDCS sessions per patient
- Number of days between the successive tDCS cures [ Time Frame: 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 [ Time Frame: 12 months ]Number and types of adverse events linked to the tDCS
- Compliance with tDCS [ Time Frame: 12 months ]number of missed sessions over the number of planned sessions, per patient
- Patient acceptability of the tDCS technique: Analog Visual Scale [ Time Frame: 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 [ Time Frame: At baseline ]patient's professional status (active, unemployed, retired...)
- Impact of the implementation of the tDCS on the organization of care [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03758105
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