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| Name | Class |
|---|---|
| University Hospital, Rouen | OTHER |
| University Hospital, Bordeaux | OTHER |
| Nantes University Hospital | OTHER |
| University Hospital, Toulouse |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroconvulsive therapy | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| The response rate (a 30% decrease in the BPRS) at different times of the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maud Rothärmel, MD | Contact | 0033232956825 | maud.rotharmel@ch-lerouvray.fr | |
| Aline Augustynen | Contact | 0033232956825 | aline.augustynen@ch-lerouvray.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Charles Perrens | Not yet recruiting | Bordeaux | 33076 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33858488 | Derived | 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. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| OTHER |
| University Hospital, Caen | OTHER |
| Centre Hospitalier Henri Laborit | OTHER |
| Centre Hospitalier St Anne | OTHER |
| Centre Hospitalier de Cadillac | OTHER |
| Hôpital Louis Mourier | OTHER |
| University Hospital, Montpellier | OTHER |
| University Hospital, Clermont-Ferrand | OTHER |
| Centre hospitalier de Ville-Evrard, France | OTHER |
A multicentric, prospective, random-assignment study incorporating both non-blinded treatment and blinded assessment
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non-blinded treatment and blinded assessment
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The response rate (a 30 % decrease in the BPRS) at 2, 4, 6 and 12 months. |
| 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. | 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. | -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. | -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. | -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. | -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. | -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. | -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. | 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. | 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. | 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. | day 1 and 2, 4, 6, 9, 12 and 15 months |
| Centre Hospitalier de Cadillac | Not yet recruiting | Cadillac | 33410 | France |
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| CHU de Caen | Recruiting | Caen | 14033 | France |
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| Clermont-Ferrand Hospital | Recruiting | Clermont-Ferrand | France |
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| Montpellier University Hospital | Recruiting | Montpellier | France |
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| CHU de Nantes | Recruiting | Nantes | 44000 | France |
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| EPS Ville Evrard | Not yet recruiting | Neuilly-sur-Marne | France |
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| Centre Hospitalier Saint Anne | Recruiting | Paris | 75014 | France |
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| Centre Hospitalier Henri Laborit | Recruiting | Poitiers | 86021 | France |
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| CHU de Toulouse | Recruiting | Toulouse | 31059 | France |
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