Schizophrenia Clinical Trial
— SURECTOfficial title:
Clinical Trial Comparing Two Electroconvulsive Therapy (ECT) Application Schemas in Ultra-resistant Schizophrenia
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.
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; |
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 |
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 |
France,
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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