ECT in Ultra-resistant Schizophrenia

  • STATUS
    Recruiting
  • End date
    Oct 4, 2023
  • participants needed
    64
  • sponsor
    Centre Hospitalier du Rouvray
Updated on 26 January 2021
antidepressants
antipsychotics
clozapine
hallucinations
chlorpromazine
mood stabilizers
psychotic symptoms
typical antipsychotic

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.

Details
Condition Electroconvulsive Therapy, Schizophrenia, Schizophrenia and Schizoaffective Disorders, Schizophrenia and Schizoaffective Disorders (Pediatric), schizophrenia disorders, electroconvulsive therapy (ect)
Treatment Electroconvulsive therapy
Clinical Study IdentifierNCT03542903
SponsorCentre Hospitalier du Rouvray
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 55 yrs?
Gender: Male or Female
Do you have any of these conditions: Electroconvulsive Therapy or Schizophrenia or Schizophrenia and Schizoaffective Disorders or Schizophrenia and Schizoaffective Disorders (Pediatric)?
Do you have any of these conditions: schizophrenia disorders or Schizophrenia and Schizoaffective Disorders (Pediatric) or Schizophrenia or Electroconvulsive Therapy or Schizophrenia and ...?
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

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 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
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