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

• ClinicalTrials.gov Identifier: NCT03758105
• Recruitment Status: Recruiting
• First Posted: November 29, 2018
• Last Update Posted: January 20, 2021
• Sponsor: Nantes University Hospital
• Information provided by (Responsible Party): Nantes University Hospital

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	Not Applicable

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 (Clinical Trial)
• Estimated 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: February 4, 2019
• Estimated Primary Completion Date: July 2023
• Estimated Study Completion Date: July 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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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
2. 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.
3. Remission rate [ Time Frame: 12 months ]
   Remission rate is defined as follows: MADRS score < 10 (see detailed description of MADRS in outcome 3)
4. 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)
5. 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)
6. 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).
7. 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.
8. 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)
9. 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
10. Rate of suicide attempts [ Time Frame: 12 months ]
    number of suicide attempts per patient
11. Rate of suicides [ Time Frame: 12 months ]
    number of suicides
12. Treatment(s) switch(es) [ Time Frame: At Baseline, one month, 2 months, 6 months and 12 months. ]
    Number of treatment switches per patient
13. 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
14. Treatments combination(s) [ Time Frame: at Baseline, one month, 2 months, 6 months and 12 months. ]
    List of drugs (name) prescribed to the patient
15. 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
16. 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.
17. Total number of tDCS sessions [ Time Frame: 12 months ]
    total number of tDCS sessions per patient
18. 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
19. Adverse events linked to tDCS [ Time Frame: 12 months ]
    Number and types of adverse events linked to the tDCS
20. Compliance with tDCS [ Time Frame: 12 months ]
    number of missed sessions over the number of planned sessions, per patient
21. 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"
22. professional status [ Time Frame: At baseline ]
    patient's professional status (active, unemployed, retired...)
23. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Anne Sauvaget, MD; +33.2.40.08.47.95; anne.sauvaget@chu-nantes.fr

Contact: Cécile DERT; +33 2 53 48 28 52; cecile.dert@chu-nantes.fr

Locations

France

CHU d'Angers; Recruiting

Angers, France

Contact: Bénédicte GOHIER, Phd 02 41 35 36 37 BeGohier@chu-angers.fr

Clinique Mirambeau; Recruiting

Anglet, France, 64600

Contact: Christophe DAUDET 33559523300 cdaudet001@yahoo.fr

CHRU de Besançon; Recruiting

Besançon, France

Contact: Emmanuel HAFFEN, Phd 03 81 66 81 66 emmanuel.haffen@univ-fcomte.fr

Chu Clermont Ferrand; Recruiting

Clermont-Ferrand, France, 63003

Contact: Pierre Michel LLORCA 33473750750 pmllorca@chu-clermontferrand.fr

CHU de Dijon; Recruiting

Dijon, France

Contact: Benoit TROJAK, Phd 03 80 29 30 31 benoit.trojak@chu-dijon.fr

Chu de Lyon; Recruiting

Lyon, France

Contact: Emmanuel POULET 33472110009 emmanuel.poulet@chu-lyon.fr

Nantes University Hospital; Recruiting

Nantes, France, 44100

Contact: Anne Sauvaget, MD +33 2 40 08 47 95 anne.sauvaget@chu-nantes.fr

Contact: Annabelle Rivalland +33 253 48 26 53 annabelle.rivalland@chu-nantes.fr

Aphp Hopital Saint Antoine; Recruiting

Paris, France

Contact: Stéphane MOUCHABAC 33149282645 stephane.mouchabac@aphp.fr

CH Henri Laborit (Poitiers); Recruiting

Poitiers, France

Contact: Nematollah JAAFARI, Phd 05 49 44 57 57 nemat.jaafari@ch-poitiers.fr

Centre hospitalier Guillaume Regnier Rennes; Recruiting

Rennes, France, 35000

Contact: dominique DRAPIER +33299333900 d.drapier@ch-guillaumeregnier.fr

CH du Rouvray - Rouen; Recruiting

Rouen, France

Contact: Maud ROTHARMEL, Md 02 32 95 12 34 maud.rotharmel@ch-lerouvray.fr

CHU de Tours / CHRU de Tours; Recruiting

Tours, France

Contact: WISSAM EL HAGE, Phd 02 47 47 47 47 W.ELHAGE@chu-tours.fr

Sponsors and Collaborators

Nantes University Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sauvaget A, Lagalice L, Schirr-Bonnans S, Volteau C, Péré 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.

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT03758105
• Other Study ID Numbers: RC17_0493
• First Posted: November 29, 2018
• Last Update Posted: January 20, 2021
• Last Verified: January 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nantes University Hospital:

Depression; psychiatry; health economics; Neurostimulation; tDCS

Additional relevant MeSH terms:

Depression; Behavioral Symptoms