ECT in Ultra-resistant Schizophrenia

NCT ID: NCT03542903

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-04
• Study Completion Date: 2023-10-04

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.

Conditions

Schizophrenia; Electroconvulsive Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Short ECT arm

In the short arm, bitemporal ECT is administered twice a week during the first 6 weeks. Afterwards, it is administered once a week during 4 weeks. After that, the patients will have one ECT every 3 weeks during 6 weeks. Lastly, patients will receive one ECT each month during 2 months.

Group Type: ACTIVE_COMPARATOR

Electroconvulsive therapy

Intervention Type: DEVICE

Electroconvulsive therapy is administered through electrodes positioned bilaterally (for quicker efficacy) on the frontotemporal region.

The stimulation dose is determined by titration method, during the first ECT session.

The dose for therapeutic stimulation will be twice the seizure threshold. This dose may be increased as the crisis does not meet the effectiveness criteria, as is recommended.

For patients undergoing ECT, an intravenous injection of etomidate (between 0.1 and 0.7 mg/kg) and suxamethonium chloride (0.8 and 1.2 mg/kg) is performed. The required doses are adapted according to each patient by the anaesthetist and they are documented in the patients' files. A mixture of etomidate and propofol can be used in second-line or just propofol in third-line (no more than 2mg/kg).

Long ECT arm

In the long arm, bitemporal ECT is administered twice a week during the first 12 weeks. Afterwards, it is administered once a week during 8 weeks. After that, the patients will have one ECT every 3 weeks during 12 weeks. Lastly, patients will receive one ECT each month during 4 months.

Group Type: ACTIVE_COMPARATOR

Electroconvulsive therapy

Intervention Type: DEVICE

Electroconvulsive therapy is administered through electrodes positioned bilaterally (for quicker efficacy) on the frontotemporal region.

The stimulation dose is determined by titration method, during the first ECT session.

The dose for therapeutic stimulation will be twice the seizure threshold. This dose may be increased as the crisis does not meet the effectiveness criteria, as is recommended.

For patients undergoing ECT, an intravenous injection of etomidate (between 0.1 and 0.7 mg/kg) and suxamethonium chloride (0.8 and 1.2 mg/kg) is performed. The required doses are adapted according to each patient by the anaesthetist and they are documented in the patients' files. A mixture of etomidate and propofol can be used in second-line or just propofol in third-line (no more than 2mg/kg).

Interventions

Electroconvulsive therapy

Electroconvulsive therapy is administered through electrodes positioned bilaterally (for quicker efficacy) on the frontotemporal region.

The stimulation dose is determined by titration method, during the first ECT session.

The dose for therapeutic stimulation will be twice the seizure threshold. This dose may be increased as the crisis does not meet the effectiveness criteria, as is recommended.

For patients undergoing ECT, an intravenous injection of etomidate (between 0.1 and 0.7 mg/kg) and suxamethonium chloride (0.8 and 1.2 mg/kg) is performed. The required doses are adapted according to each patient by the anaesthetist and they are documented in the patients' files. A mixture of etomidate and propofol can be used in second-line or just propofol in third-line (no more than 2mg/kg).

Intervention Type: DEVICE

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: collaborator

University Hospital, Caen

OTHER

Sponsor Role: collaborator

Centre Hospitalier Henri Laborit

OTHER

Sponsor Role: collaborator

Centre Hospitalier St Anne

OTHER

Sponsor Role: collaborator

Centre Hospitalier de Cadillac

OTHER

Sponsor Role: collaborator

Hôpital Louis Mourier

OTHER

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: collaborator

Centre hospitalier de Ville-Evrard, France

OTHER

Sponsor Role: collaborator

Centre Hospitalier du Rouvray

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Charles Perrens

Bordeaux, , France

Site Status: NOT_YET_RECRUITING

Centre Hospitalier de Cadillac

Cadillac, , France

Site Status: NOT_YET_RECRUITING

CHU de Caen

Caen, , France

Site Status: RECRUITING

Clermont-Ferrand Hospital

Clermont-Ferrand, , France

Site Status: RECRUITING

Montpellier University Hospital

Montpellier, , France

Site Status: RECRUITING

CHU de Nantes

Nantes, , France

Site Status: RECRUITING

EPS Ville Evrard

Neuilly-sur-Marne, , France

Site Status: NOT_YET_RECRUITING

Centre Hospitalier Saint Anne

Paris, , France

Site Status: RECRUITING

Centre Hospitalier Henri Laborit

Poitiers, , France

Site Status: RECRUITING

CHU de Toulouse

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Maud Rothärmel, MD

Role: CONTACT

maud.rotharmel@ch-lerouvray.fr

0033232956825

Aline Augustynen

Role: CONTACT

aline.augustynen@ch-lerouvray.fr

0033232956825

Facility Contacts

Clelia Quiles, Md,PhD

Role: primary

Patrick Le Bihan, MD

Role: primary

Pierrick Lebain, MD

Role: primary

Pierre-Michel Llorca, MD, PhD

Role: primary

Jerôme Attal, MD

Role: primary

Anne Sauvaget, MD,PhD

Role: primary

Dominique Januel, MD, PhD

Role: primary

Marie-Odile Krebs, MD,PhD

Role: primary

Nemat Jaafari, MD,PhD

Role: primary

Christophe Arbus, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 33858488 (View on PubMed)

Other Identifiers

2017-A02657-46

Identifier Type: -

Identifier Source: org_study_id