ECT in Ultra-resistant Schizophrenia

Last updated: September 15, 2020
Sponsor: Centre Hospitalier du Rouvray
Overall Status: Active - Recruiting

Phase

N/A

Condition

Psychosis

Mood Disorders

Tourette's Syndrome

Treatment

N/A

Clinical Study ID

NCT03542903
2017-A02657-46
  • Ages 18-55
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with URS: patients who continue to experience persistent positive psychoticsymptoms: item score of 4 (moderate) on at least two of four positive symptoms on theBPRS (grandiosity, suspiciousness, hallucinations and unusual thoughts), currentpresence of at least moderately severe illness on the total BPRS-18 (45) and a scoreof 4 (moderate) on the CGI-S, despite a period of clozapine therapy of at least 6weeks with a plasma concentration of 350 ng/ml and at least two unsuccessful previoustreatment trials with conventional or atypical antipsychotic drugs from two distinctfamilies at a dose 600 mg of chlorpromazine equivalents.

  • Age: from 18 to 55

  • Patients with stable treatments for at least 8 weeks (antipsychotics, mood stabilizersand antidepressants).

  • Participants who gave their informed, written consents and agreement of their guardianfor the patients under guardianship

  • Patients deprived of liberty if they gave their informed, written consents

Exclusion

Exclusion Criteria:

  • Current affective episode according to DSM-5 criteria;

  • ECT within (the last) 6 months;

  • Unstable epilepsy ; severe neurological or systemic disorder that could significantlyaffect cognition, behavior, or mental status (other than late dyskinesia orneuroleptic-induced parkinsonism);

  • Severe substance use disorders (other than nicotine or caffeine) according to DSM-5criteria.

  • 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 trialwithin 30 days prior to the inclusion visit;

Study Design

Total Participants: 64
Study Start date:
July 04, 2018
Estimated Completion Date:
October 04, 2023

Connect with a study center

  • Centre Hospitalier Charles Perrens

    Bordeaux, 33076
    France

    Site Not Available

  • Centre Hospitalier de Cadillac

    Cadillac, 33410
    France

    Site Not Available

  • CHU de Caen

    Caen, 14033
    France

    Active - Recruiting

  • Clermont-Ferrand Hospital

    Clermont-Ferrand,
    France

    Active - Recruiting

  • Montpellier University Hospital

    Montpellier,
    France

    Active - Recruiting

  • CHU de Nantes

    Nantes, 44000
    France

    Active - Recruiting

  • EPS Ville Evrard

    Neuilly-sur-Marne,
    France

    Site Not Available

  • Centre Hospitalier Saint Anne

    Paris, 75014
    France

    Active - Recruiting

  • Centre Hospitalier Henri Laborit

    Poitiers, 86021
    France

    Active - Recruiting

  • CHU de Toulouse

    Toulouse, 31059
    France

    Active - Recruiting

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