Informations générales (source: ClinicalTrials.gov)
Cost-utility Analysis of Maintenance rTMS for Treatment-resistant Depression (ACOUSTIM)
Interventional
N/A
Nantes University Hospital (Voir sur ClinicalTrials)
novembre 2018
décembre 2023
07 septembre 2024
Treatment resistant depression (TRD) is a frequent, debilitating condition mostly treated
by antidepressants. Repeated magnetic transcranial stimulation (rTMS) has proven adjuvant
efficacy in TRD in the acute phase of treatment with a very good tolerance and
acceptability. Maintenance rTMS (mTMS) is a strategy consisting in adding regular single
TMS sessions after response to an acute course in order to keep the benefit of initial
treatment over several month or years. Demonstrating that rTMS is efficient to improve
long-term prognosis and decrease economic burden would have a tremendous impact in
clinical practice in psychiatry. Thus the investigator's aim is to analyze the long term
impact of mTMS treatment on costs, but also quality of life and clinical issues.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| ET.PUBLIC DE SANTE VILLE-EVRARD | Contact (sur clinicalTrials) | ||||
| UNITE HOSPI ST ANNE SITE HENRY EY | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre hospitalier Guillaume Regnier Rennes - 35000 - Rennes - France | Contact (sur clinicalTrials) | ||||
| CH du Rouvray - Rouen - Rouen - France | Contact (sur clinicalTrials) | ||||
| CH Henri Laborit (Poitiers) - 86000 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| CHRU de Besançon - 25000 - Besançon - France | Contact (sur clinicalTrials) | ||||
| CHU d'Angers - 49100 - Angers - France | Contact (sur clinicalTrials) | ||||
| CHU de Caen - Caen - France | Contact (sur clinicalTrials) | ||||
| CHU de Clermont-Ferrand - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| CHU de Dijon - Dijon - France | Contact (sur clinicalTrials) | ||||
| CHU de Montpellier - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Clinique de Vontes - Esvre-sur-Indre - France | Contact (sur clinicalTrials) | ||||
| EPSM de Lille - Lille - France | Contact (sur clinicalTrials) | ||||
| Nantes University Hospital - 44000 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH Esquirol - Limoges - Limoges - France | Contact (sur clinicalTrials) | ||||
| CH le Vinatier Lyon - Bron - France | Contact (sur clinicalTrials) | ||||
| CHU de Toulouse - Toulouse - France | Contact (sur clinicalTrials) | ||||
| CHU de Tours / CHRU de Tours - 37540 - Tours - France | Contact (sur clinicalTrials) | ||||
| GH PItié Salpétrière - Paris - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Major depressive disorder according to Diagnostic and Statistical Manual of Mental
Disorders (DSM) 5 MADRS >19
- Episode duration: 12 weeks to 3 years.
- 2 to 4 unsuccessful treatment lines (including antidepressants, and potentialization
agents lithium and quetiapine) despite adequate dosage and duration (6 weeks stable
posology)
- Ability to consent and express informed consent, to answer questionnaires and to go
to follow-up visits.
- Affiliation to social security
- Major depressive disorder according to Diagnostic and Statistical Manual of Mental
Disorders (DSM) 5 MADRS >19
- Episode duration: 12 weeks to 3 years.
- 2 to 4 unsuccessful treatment lines (including antidepressants, and potentialization
agents lithium and quetiapine) despite adequate dosage and duration (6 weeks stable
posology)
- Ability to consent and express informed consent, to answer questionnaires and to go
to follow-up visits.
- Affiliation to social security
- Bipolar disorder
- Schizophrenia and other psychotic disorders
- Mental retardation or developmental disorder
- Substance abuse or dependence
- Depression symptoms better explained by medical conditions
- Neurologic conditions (e.g.,previous epilepsy or unexplained seizures, stroke,
trauma, infection, metabolic disease, severe migraines, multiple sclerosis, brain
tumor)
- Presence of at least one contra-indication to rTMS
- Pregnancy/breast-feeding
- Patient who previously received 5 lines or more pharmacological treatment for the
current episode (excluding symptomatic psychotropic drugs, e.g. benzodiazepines and
hypnotics)
- Former use of electroconvulsive therapy or rTMS within the current episode.
- Previous failure of adequate ECT (at least 12 well conducted sessions) or rTMS
course (at least 20 well conducted sessions) in the medical history.
- History of at least two courses of ECT, previous need for maintenance ECT.
- Protection measure : maintenance of justice, tutelage, legal guardianship
- Woman of childbearing age without effective contraception
- Liberty deprivation (e.g. incarceration, therapeutic injunction)