Clinical trial NCT03542903: ECT in Ultra-resistant Schizophrenia
Official title: Clinical Trial Comparing Two Electroconvulsive Therapy (ECT) Application Schemas in Ultra-resistant Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Electroconvulsive Therapy
Lead sponsor: Centre Hospitalier du Rouvray
Sponsor class: OTHER_GOV
Collaborators: name: University Hospital, Rouen
name: University Hospital, Bordeaux
name: Nantes University Hospital
name: University Hospital, Toulouse
name: University Hospital, Caen
name: Centre Hospitalier Henri Laborit
name: Centre Hospitalier St Anne
name: Centre Hospitalier de Cadillac
name: Hôpital Louis Mourier
name: University Hospital, Montpellier
name: University Hospital, Clermont-Ferrand
name: Centre hospitalier de Ville-Evrard, France
First posted: 2018-05-31
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicentric, prospective, random-assignment study incorporating both non-blinded treatment and blinded assessment
Primary purpose: TREATMENT

Brief 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 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

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;

Primary outcomes:
measure: The response rate (a 30% decrease in the Positive and Negative Syndrome Scale (PANSS)) at 15th month
timeFrame: three months after the end of the treatment (i.e. 9 and 15 months)
Secondary outcomes:
measure: The response rate (a 30% decrease in the Brief Psychiatric Rating Scale (BPRS))
timeFrame: three months after the end of the treatment (i.e. 9 and 15 months)
measure: The response rate (a 30% decrease in the BPRS) at different times of the study
timeFrame: 2, 4, 6 and 12 months
measure: Response rate (a 30% decrease in the PANSS) at different times of the study
timeFrame: 2, 4, 6 and 12 months
measure: Neuropsychological assessment- MMSE
timeFrame: -1, 6 and 15 months
measure: Neuropsychological assessment- SSTICS
timeFrame: -1, 6 and 15 months
measure: Neuropsychological assessment- Grober and Buschke test
timeFrame: -1, 6 and 15 months
measure: Neuropsychological assessment- test of doors
timeFrame: -1, 6 and 15 months
measure: Neuropsychological assessment- test of d2
timeFrame: -1, 6 and 15 months
measure: Neuropsychological assessment - "figure de Rey" test
timeFrame: -1, 6 and 15 months
measure: Other clinical assessment- HAMD-21
timeFrame: day 1 and 2, 4, 6, 9, 12 and 15 months
measure: Other clinical assessment-YMRS
timeFrame: day 1 and 2, 4, 6, 9, 12 and 15 months
measure: Other clinical assessment-GAF
timeFrame: day 1 and 2, 4, 6, 9, 12 and 15 months
measure: Other clinical assessment-MOAS
timeFrame: day 1 and 2, 4, 6, 9, 12 and 15 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Charles Perrens
city: Cadillac
country: France
facility: Centre Hospitalier de Cadillac
city: Caen
country: France
facility: CHU de Caen
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand Hospital
city: Montpellier
country: France
facility: Montpellier University Hospital
city: Nantes
country: France
facility: CHU de Nantes
city: Neuilly-sur-Marne
country: France
facility: EPS Ville Evrard
city: Paris
country: France
facility: Centre Hospitalier Saint Anne
city: Poitiers
country: France
facility: Centre Hospitalier Henri Laborit
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
References:
citation: Moulier V, Krir MW, Dalmont M; SURECT Group; Guillin O, Rotharmel M. A prospective multicenter assessor-blinded randomized controlled study to compare the efficacy of short versus long protocols of electroconvulsive therapy as an augmentation strategy to clozapine in patients with ultra-resistant schizophrenia (SURECT study). Trials. 2021 Apr 15;22(1):284. doi: 10.1186/s13063-021-05227-3.