Informations générales (source: ClinicalTrials.gov)
Clinical Trial Comparing Two Electroconvulsive Therapy (ECT) Application Schemas in Ultra-resistant Schizophrenia (SURECT)
Interventional
N/A
Centre Hospitalier du Rouvray (Voir sur ClinicalTrials)
juillet 2018
octobre 2023
29 juin 2024
The effects of the ECT in schizophrenia ultra-resistant were studied in short times (4-6
months in most studies with follow-up). The literature identified a high relapse rate of
32% in the weeks to months after ECT discontinuation. The use of the ECT in the
prevention of the relapse is partially known. In an empirical way, experts recommend
protocols of prevention of the relapse going from 6 to 12 months. Nevertheless, the
profit of a long cure (12 months) compared with a short cure (6 months) was never
determined. Therefore, the investigators decided to lead a prospective randomized
controlled study in order to compare the response rates between the two strategies of
clozapine and ECT combinations applied to URS patients. The treatment consisted either in
a short therapy of six months or a longer course of therapy of twelve months. To the
investigators' knowledge, it is the first study which compares two ECT strategies (both
the short duration and the longer one) for the treatment of URS patients.
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 | Dominique Januel, MD, PhD | 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 Saint Anne - 75014 - Paris - France | Marie-Odile Krebs, MD,PhD | 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 | |||||
| Centre Hospitalier Charles Perrens - 33076 - Bordeaux - France | Clelia Quiles, Md,PhD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de Cadillac - 33410 - Cadillac - France | Patrick Le Bihan, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Henri Laborit - 86021 - Poitiers - France | Nemat Jaafari, MD,PhD | Contact (sur clinicalTrials) | |||
| CHU de Caen - 14033 - Caen - France | Pierrick Lebain, MD | Contact (sur clinicalTrials) | |||
| CHU de Nantes - 44000 - Nantes - France | Anne Sauvaget, MD,PhD | Contact (sur clinicalTrials) | |||
| CHU de Toulouse - 31059 - Toulouse - France | Christophe Arbus, MD | Contact (sur clinicalTrials) | |||
| Clermont-Ferrand Hospital - Clermont-Ferrand - France | Pierre-Michel Llorca, MD, PhD | Contact (sur clinicalTrials) | |||
| Montpellier University Hospital - Montpellier - France | Jerôme Attal, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patients with URS: patients who continue to experience persistent positive psychotic
symptoms: item score of 4 (moderate) on at least two of four positive symptoms on
the BPRS (grandiosity, suspiciousness, hallucinations and unusual thoughts), current
presence of at least moderately severe illness on the total BPRS-18 (45) and a score
of 4 (moderate) on the CGI-S, despite a period of clozapine therapy of at least 6
weeks with a plasma concentration of 350 ng/ml and at least two unsuccessful
previous treatment trials with conventional or atypical antipsychotic drugs from two
distinct families at a dose 600 mg of chlorpromazine equivalents.
- Age: from 18 to 55
- Patients with stable treatments for at least 8 weeks (antipsychotics, mood
stabilizers and antidepressants).
- Participants who gave their informed, written consents and agreement of their
guardian for the patients under guardianship
- Patients deprived of liberty if they gave their informed, written consents
- Patients with URS: patients who continue to experience persistent positive psychotic
symptoms: item score of 4 (moderate) on at least two of four positive symptoms on
the BPRS (grandiosity, suspiciousness, hallucinations and unusual thoughts), current
presence of at least moderately severe illness on the total BPRS-18 (45) and a score
of 4 (moderate) on the CGI-S, despite a period of clozapine therapy of at least 6
weeks with a plasma concentration of 350 ng/ml and at least two unsuccessful
previous treatment trials with conventional or atypical antipsychotic drugs from two
distinct families at a dose 600 mg of chlorpromazine equivalents.
- Age: from 18 to 55
- Patients with stable treatments for at least 8 weeks (antipsychotics, mood
stabilizers and antidepressants).
- Participants who gave their informed, written consents and agreement of their
guardian for the patients under guardianship
- Patients deprived of liberty if they gave their informed, written consents
- Current affective episode according to DSM-5 criteria;
- ECT within (the last) 6 months;
- Unstable epilepsy ; severe neurological or systemic disorder that could
significantly affect cognition, behavior, or mental status (other than late
dyskinesia or neuroleptic-induced parkinsonism);
- Severe substance use disorders (other than nicotine or caffeine) according to DSM-5
criteria.
- Concomitant use of antiepileptics and benzodiazepines apart from lamotrigine
- Women of childbearing age with no adequate contraception, pregnant or lactating
women;
- Patients having contraindications to etomidate or any of its excipients;
- Patients having contraindications to neuromuscular blocking agents;
- Patients participating or having participated in an interventional clinical trial
within 30 days prior to the inclusion visit;