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ECT in Ultra-resistant Schizophrenia (SURECT)

Primary Purpose

Schizophrenia, Electroconvulsive Therapy

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electroconvulsive therapy
Sponsored by
Centre Hospitalier du Rouvray
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Centre Hospitalier Charles Perrens
  • Centre Hospitalier de Cadillac
  • CHU de CaenRecruiting
  • Clermont-Ferrand HospitalRecruiting
  • Montpellier University HospitalRecruiting
  • CHU de NantesRecruiting
  • EPS Ville Evrard
  • Centre Hospitalier Saint AnneRecruiting
  • Centre Hospitalier Henri LaboritRecruiting
  • CHU de ToulouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Short ECT arm

Long ECT arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The response rate (a 30% decrease in the Brief Psychiatric Rating Scale (BPRS))
The response rate (a 30% decrease in the BPRS, ranging from 18, the minimum, to 126, the most severe score) at 15th month.
The response rate (a 30% decrease in the BPRS) at different times of the study
The response rate (a 30 % decrease in the BPRS) at 2, 4, 6 and 12 months.
Response rate (a 30% decrease in the PANSS) at different times of the study
The response rate (a 30 % decrease in the PANSS) at 2, 4, 6 and 12 months.
Neuropsychological assessment- MMSE
The scores and variations of the Mini Mental Status Examination (MMSE) at -1, 6 and 15 months.
Neuropsychological assessment- SSTICS
The scores and variations of the Subjective Scale To Investigate Cognition In Schizophrenia (SSTICS, scores ranging from 0 to 84, the most severe score) at -1, 6 and 15 months.
Neuropsychological assessment- Grober and Buschke test
The scores and variations of the test of Grober and Buschke at -1, 6 and 15 months.
Neuropsychological assessment- test of doors
The scores and variations of the test of doors at -1, 6 and 15 months.
Neuropsychological assessment- test of d2
The scores and variations of the test of d2 at -1, 6 and 15 months.
Neuropsychological assessment - "figure de Rey" test
the scores ans variations of the test of " figure de Rey" at -1, 6 and 15 months.
Other clinical assessment- HAMD-21
The scores and variations of the Hamilton Rating Scale-21 items (HAMD-21, scores ranging from 0 to 64, the most severe score) at day 1 and 2, 4, 6, 9, 12 and 15 months.
Other clinical assessment-YMRS
The scores and variations of the Young Mania Rating Scale (YMRS, scores ranging from 0 to 60, the most severe score) at day 1 and 2, 4, 6, 9, 12 and 15 months.
Other clinical assessment-GAF
The scores and variations of the Global Assessment Functioning (GAF, scores ranging from 0 to 100, the best score) at day 1 and 2, 4, 6, 9, 12 and 15 months.
Other clinical assessment-MOAS
The scores and variations of the Modified Overt Aggression Scale (MOAS, scores ranging from 0 to 100, the most severe score) at day 1 and 2, 4, 6, 9, 12 and 15 months.

Full Information

First Posted
April 11, 2018
Last Updated
September 15, 2020
Sponsor
Centre Hospitalier du Rouvray
Collaborators
University Hospital, Rouen, University Hospital, Bordeaux, Nantes University Hospital, University Hospital, Toulouse, University Hospital, Caen, Centre Hospitalier Henri Laborit, Centre Hospitalier St Anne, Centre Hospitalier de Cadillac, Hôpital Louis Mourier, University Hospital, Montpellier, University Hospital, Clermont-Ferrand, Centre hospitalier de Ville-Evrard, France
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1. Study Identification

Unique Protocol Identification Number
NCT03542903
Brief Title
ECT in Ultra-resistant Schizophrenia
Acronym
SURECT
Official Title
Clinical Trial Comparing Two Electroconvulsive Therapy (ECT) Application Schemas in Ultra-resistant Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 4, 2018 (Actual)
Primary Completion Date
October 4, 2023 (Anticipated)
Study Completion Date
October 4, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier du Rouvray
Collaborators
University Hospital, Rouen, University Hospital, Bordeaux, Nantes University Hospital, University Hospital, Toulouse, University Hospital, Caen, Centre Hospitalier Henri Laborit, Centre Hospitalier St Anne, Centre Hospitalier de Cadillac, Hôpital Louis Mourier, University Hospital, Montpellier, University Hospital, Clermont-Ferrand, Centre hospitalier de Ville-Evrard, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Electroconvulsive Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A multicentric, prospective, random-assignment study incorporating both non-blinded treatment and blinded assessment
Masking
Outcomes Assessor
Masking Description
non-blinded treatment and blinded assessment
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Short ECT arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Long ECT arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Electroconvulsive therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
The response rate (a 30% decrease in the Positive and Negative Syndrome Scale (PANSS)) at 15th month
Description
The response rate (a 30% decrease in the PANSS, ranging from 30, the minimum, to 210, the most severe score) at 15th month
Time Frame
three months after the end of the treatment (i.e. 9 and 15 months)
Secondary Outcome Measure Information:
Title
The response rate (a 30% decrease in the Brief Psychiatric Rating Scale (BPRS))
Description
The response rate (a 30% decrease in the BPRS, ranging from 18, the minimum, to 126, the most severe score) at 15th month.
Time Frame
three months after the end of the treatment (i.e. 9 and 15 months)
Title
The response rate (a 30% decrease in the BPRS) at different times of the study
Description
The response rate (a 30 % decrease in the BPRS) at 2, 4, 6 and 12 months.
Time Frame
2, 4, 6 and 12 months
Title
Response rate (a 30% decrease in the PANSS) at different times of the study
Description
The response rate (a 30 % decrease in the PANSS) at 2, 4, 6 and 12 months.
Time Frame
2, 4, 6 and 12 months
Title
Neuropsychological assessment- MMSE
Description
The scores and variations of the Mini Mental Status Examination (MMSE) at -1, 6 and 15 months.
Time Frame
-1, 6 and 15 months
Title
Neuropsychological assessment- SSTICS
Description
The scores and variations of the Subjective Scale To Investigate Cognition In Schizophrenia (SSTICS, scores ranging from 0 to 84, the most severe score) at -1, 6 and 15 months.
Time Frame
-1, 6 and 15 months
Title
Neuropsychological assessment- Grober and Buschke test
Description
The scores and variations of the test of Grober and Buschke at -1, 6 and 15 months.
Time Frame
-1, 6 and 15 months
Title
Neuropsychological assessment- test of doors
Description
The scores and variations of the test of doors at -1, 6 and 15 months.
Time Frame
-1, 6 and 15 months
Title
Neuropsychological assessment- test of d2
Description
The scores and variations of the test of d2 at -1, 6 and 15 months.
Time Frame
-1, 6 and 15 months
Title
Neuropsychological assessment - "figure de Rey" test
Description
the scores ans variations of the test of " figure de Rey" at -1, 6 and 15 months.
Time Frame
-1, 6 and 15 months
Title
Other clinical assessment- HAMD-21
Description
The scores and variations of the Hamilton Rating Scale-21 items (HAMD-21, scores ranging from 0 to 64, the most severe score) at day 1 and 2, 4, 6, 9, 12 and 15 months.
Time Frame
day 1 and 2, 4, 6, 9, 12 and 15 months
Title
Other clinical assessment-YMRS
Description
The scores and variations of the Young Mania Rating Scale (YMRS, scores ranging from 0 to 60, the most severe score) at day 1 and 2, 4, 6, 9, 12 and 15 months.
Time Frame
day 1 and 2, 4, 6, 9, 12 and 15 months
Title
Other clinical assessment-GAF
Description
The scores and variations of the Global Assessment Functioning (GAF, scores ranging from 0 to 100, the best score) at day 1 and 2, 4, 6, 9, 12 and 15 months.
Time Frame
day 1 and 2, 4, 6, 9, 12 and 15 months
Title
Other clinical assessment-MOAS
Description
The scores and variations of the Modified Overt Aggression Scale (MOAS, scores ranging from 0 to 100, the most severe score) at day 1 and 2, 4, 6, 9, 12 and 15 months.
Time Frame
day 1 and 2, 4, 6, 9, 12 and 15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maud Rothärmel, MD
Phone
0033232956825
Email
maud.rotharmel@ch-lerouvray.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Aline Augustynen
Phone
0033232956825
Email
aline.augustynen@ch-lerouvray.fr
Facility Information:
Facility Name
Centre Hospitalier Charles Perrens
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clelia Quiles, Md,PhD
First Name & Middle Initial & Last Name & Degree
Clelia Quiles, MD,PhD
Facility Name
Centre Hospitalier de Cadillac
City
Cadillac
ZIP/Postal Code
33410
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Le Bihan, MD
First Name & Middle Initial & Last Name & Degree
Patrick Le Bihan, MD
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierrick Lebain, MD
First Name & Middle Initial & Last Name & Degree
Pierrick Lebain, MD
First Name & Middle Initial & Last Name & Degree
Clément Nathou, MD, PhD
First Name & Middle Initial & Last Name & Degree
Sonia Dollfus, MD,PhD
Facility Name
Clermont-Ferrand Hospital
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Michel Llorca, MD, PhD
Facility Name
Montpellier University Hospital
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerôme Attal, MD
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Sauvaget, MD,PhD
First Name & Middle Initial & Last Name & Degree
Anne Sauvaget, MD,PhD
First Name & Middle Initial & Last Name & Degree
Samuel Bulteau, MD,PhD
First Name & Middle Initial & Last Name & Degree
Jean-Marie Vanelle, MD,PhD
First Name & Middle Initial & Last Name & Degree
Edouard Laforgue, MD
Facility Name
EPS Ville Evrard
City
Neuilly-sur-Marne
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Januel, MD, PhD
First Name & Middle Initial & Last Name & Degree
Noomane Bouaziz, MD
First Name & Middle Initial & Last Name & Degree
Dominique Januel, MD, PhD
Facility Name
Centre Hospitalier Saint Anne
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Odile Krebs, MD,PhD
First Name & Middle Initial & Last Name & Degree
Marie-Odile Krebs, MD,PhD
First Name & Middle Initial & Last Name & Degree
Marion Plaze, MD
Facility Name
Centre Hospitalier Henri Laborit
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nemat Jaafari, MD,PhD
First Name & Middle Initial & Last Name & Degree
Nemat Jaafari, Md,PhD
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Arbus, MD
First Name & Middle Initial & Last Name & Degree
Christophe Arbus, MD
First Name & Middle Initial & Last Name & Degree
Marie Sporer, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33858488
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.
Results Reference
derived

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ECT in Ultra-resistant Schizophrenia

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