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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03542903
Other study ID # 2017-A02657-46
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 4, 2018
Est. completion date October 4, 2023

Study information

Verified date September 2020
Source Centre Hospitalier du Rouvray
Contact Maud Rothärmel, MD
Phone 0033232956825
Email maud.rotharmel@ch-lerouvray.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date October 4, 2023
Est. primary completion date October 4, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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;

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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).

Locations

Country Name City State
France Centre Hospitalier Charles Perrens Bordeaux
France Centre Hospitalier de Cadillac Cadillac
France CHU de Caen Caen
France Clermont-Ferrand Hospital Clermont-Ferrand
France Montpellier University Hospital Montpellier
France CHU de Nantes Nantes
France EPS Ville Evrard Neuilly-sur-Marne
France Centre Hospitalier Saint Anne Paris
France Centre Hospitalier Henri Laborit Poitiers
France CHU de Toulouse Toulouse

Sponsors (13)

Lead Sponsor Collaborator
Centre Hospitalier du Rouvray Centre Hospitalier de Cadillac, Centre hospitalier de Ville-Evrard, France, Centre Hospitalier Henri Laborit, Centre Hospitalier St Anne, Hôpital Louis Mourier, Nantes University Hospital, University Hospital, Bordeaux, University Hospital, Caen, University Hospital, Clermont-Ferrand, University Hospital, Montpellier, University Hospital, Rouen, University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. three months after the end of the treatment (i.e. 9 and 15 months)
Secondary 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. 2, 4, 6 and 12 months
Secondary 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. 2, 4, 6 and 12 months
Secondary Neuropsychological assessment- MMSE The scores and variations of the Mini Mental Status Examination (MMSE) at -1, 6 and 15 months. -1, 6 and 15 months
Secondary 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. -1, 6 and 15 months
Secondary Neuropsychological assessment- Grober and Buschke test The scores and variations of the test of Grober and Buschke at -1, 6 and 15 months. -1, 6 and 15 months
Secondary Neuropsychological assessment- test of doors The scores and variations of the test of doors at -1, 6 and 15 months. -1, 6 and 15 months
Secondary Neuropsychological assessment- test of d2 The scores and variations of the test of d2 at -1, 6 and 15 months. -1, 6 and 15 months
Secondary Neuropsychological assessment - "figure de Rey" test the scores ans variations of the test of " figure de Rey" at -1, 6 and 15 months. -1, 6 and 15 months
Secondary 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. day 1 and 2, 4, 6, 9, 12 and 15 months
Secondary 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. day 1 and 2, 4, 6, 9, 12 and 15 months
Secondary 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. day 1 and 2, 4, 6, 9, 12 and 15 months
Secondary 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. day 1 and 2, 4, 6, 9, 12 and 15 months
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