NCT03542903

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

July 4, 2018

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2023

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

5.3 years

First QC Date

April 11, 2018

Last Update Submit

September 15, 2020

Conditions

SchizophreniaElectroconvulsive Therapy

Outcome Measures

Primary Outcomes (1)

  • The response rate (a 30% decrease in the Positive and Negative Syndrome Scale (PANSS)) at 15th month

    The response rate (a 30% decrease in the PANSS, ranging from 30, the minimum, to 210, the most severe score) at 15th month

    three months after the end of the treatment (i.e. 9 and 15 months)

Secondary Outcomes (13)

  • The response rate (a 30% decrease in the Brief Psychiatric Rating Scale (BPRS))

    three months after the end of the treatment (i.e. 9 and 15 months)

  • The response rate (a 30% decrease in the BPRS) at different times of the study

    2, 4, 6 and 12 months

  • Response rate (a 30% decrease in the PANSS) at different times of the study

    2, 4, 6 and 12 months

  • Neuropsychological assessment- MMSE

    -1, 6 and 15 months

  • Neuropsychological assessment- SSTICS

    -1, 6 and 15 months

  • +8 more secondary outcomes

Study Arms (2)

Short ECT arm

ACTIVE COMPARATOR

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.

Device: Electroconvulsive therapy

Long ECT arm

ACTIVE COMPARATOR

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.

Device: Electroconvulsive therapy

Interventions

Electroconvulsive therapyDEVICE

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 armShort ECT arm

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Centre Hospitalier Charles Perrens

Bordeaux, 33076, France

NOT YET RECRUITING

Centre Hospitalier de Cadillac

Cadillac, 33410, France

NOT YET RECRUITING

CHU de Caen

Caen, 14033, France

RECRUITING

Clermont-Ferrand Hospital

Clermont-Ferrand, France

RECRUITING

Montpellier University Hospital

Montpellier, France

RECRUITING

CHU de Nantes

Nantes, 44000, France

RECRUITING

EPS Ville Evrard

Neuilly-sur-Marne, France

NOT YET RECRUITING

Centre Hospitalier Saint Anne

Paris, 75014, France

RECRUITING

Centre Hospitalier Henri Laborit

Poitiers, 86021, France

RECRUITING

CHU de Toulouse

Toulouse, 31059, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33858488DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Maud Rothärmel, MD

CONTACT

0033232956825maud.rotharmel@ch-lerouvray.fr

Aline Augustynen

CONTACT

0033232956825aline.augustynen@ch-lerouvray.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
non-blinded treatment and blinded assessment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A multicentric, prospective, random-assignment study incorporating both non-blinded treatment and blinded assessment
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2018

First Posted

May 31, 2018

Study Start

July 4, 2018

Primary Completion

October 4, 2023

Study Completion

October 4, 2023

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(10)