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

February 24, 2023 updated by: Nantes University Hospital

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
214

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Angers, France
        • CHU d'Angers
      • Anglet, France, 64600
        • Clinique Mirambeau
      • Besançon, France
        • CHRU De Besancon
      • Clermont-Ferrand, France, 63003
        • Chu Clermont Ferrand
      • Dijon, France
        • Chu de Dijon
      • Lyon, France
        • CHU de Lyon
      • Nantes, France, 44100
        • Nantes University Hospital
      • Paris, France
        • APHP Hôpital Saint Antoine
      • Poitiers, France
        • CH Henri Laborit (Poitiers)
      • Rennes, France, 35000
        • Centre hospitalier Guillaume Regnier Rennes
      • Rouen, France
        • CH du Rouvray - Rouen
      • Tours, France
        • CHU de Tours / CHRU de Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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.
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
Remission rate is defined as follows: MADRS score < 10 (see detailed description of MADRS in outcome 3)
12 months
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)
12 months
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)
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.
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).
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.
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.
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.
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)
At Baseline, one month, 2 months, 6 months and 12 months.
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
12 months
Rate of suicide attempts
Time Frame: 12 months
number of suicide attempts per patient
12 months
Rate of suicides
Time Frame: 12 months
number of suicides
12 months
Treatment(s) switch(es)
Time Frame: At Baseline, one month, 2 months, 6 months and 12 months.
Number of treatment switches per patient
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.
Number of drug(s) dose(s) increases prescribed to the patient
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.
List of drugs (name) prescribed to the patient
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
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
at baseline and at 12 months
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.
at baseline and at 12 months
Total number of tDCS sessions
Time Frame: 12 months
total number of tDCS sessions per patient
12 months
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
12 months
Adverse events linked to tDCS
Time Frame: 12 months
Number and types of adverse events linked to the tDCS
12 months
Compliance with tDCS
Time Frame: 12 months
number of missed sessions over the number of planned sessions, per patient
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)
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"
at the end of the first tDCS cure (up to one month)
professional status
Time Frame: At baseline
patient's professional status (active, unemployed, retired...)
At baseline
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 4, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 11, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 11, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2018

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC17_0493

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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