NCT03758105

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
214

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable depression

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 4, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2023

Completed
Last Updated

February 27, 2023

Status Verified

February 1, 2023

Enrollment Period

4.8 years

First QC Date

November 23, 2018

Last Update Submit

February 24, 2023

Conditions

Depression

Keywords

Depressionpsychiatryhealth economicsNeurostimulationtDCS

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (23)

  • Budget impact analysis of spreading the most efficient strategy for using tDCS

    5 years

  • Response rate

    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

    12 months

  • Relapse-free survival

    12 months

  • MADRS score

    At Baseline, one month, 2 months, 6 months and 12 months.

  • +18 more secondary outcomes

Study Arms (2)

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.

Other: tDCS associated with usual care

Usual care without tDCS (Arm B)

ACTIVE COMPARATOR

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

Other: Usual care

Interventions

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 care and tDCS (Arm A)
Usual careOTHER

Medication and psychotherapy as prescribed in usual care

Usual care without tDCS (Arm B)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

CHU d'Angers

Angers, France

Location

Clinique Mirambeau

Anglet, 64600, France

Location

CHRU de Besançon

Besançon, France

Location

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

CHU de Dijon

Dijon, France

Location

Chu de Lyon

Lyon, France

Location

Nantes University Hospital

Nantes, 44100, France

Location

Aphp Hopital Saint Antoine

Paris, France

Location

CH Henri Laborit (Poitiers)

Poitiers, France

Location

Centre hospitalier Guillaume Regnier Rennes

Rennes, 35000, France

Location

CH du Rouvray - Rouen

Rouen, France

Location

CHU de Tours / CHRU de Tours

Tours, France

Location

Related Publications (1)

  • 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.

    PMID: 31937653DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2018

First Posted

November 29, 2018

Study Start

February 4, 2019

Primary Completion

November 11, 2023

Study Completion

November 11, 2023

Last Updated

February 27, 2023

Record last verified: 2023-02

Locations

FR(12)