The Optimal Treatment for Treatment-resistant Schizophrenia
Кључне речи
Апстрактан
Опис
To explore the curative effect and safety of Risperidone，aripiprazole，sodium valproate，modified electroconvulsive therapy(MECT), or Magnetic seizure therapy(MST) with Clozapine in the treatment of treatment-resistant schizophrenia， and to provide the basis for clinical medication.
Датуми
| Последња верификација: | 09/30/2017 |
| Фирст Субмиттед: | 10/04/2016 |
| Предвиђена пријава послата: | 10/04/2016 |
| Прво објављено: | 10/05/2016 |
| Послато последње ажурирање: | 03/10/2019 |
| Последње ажурирање објављено: | 03/12/2019 |
| Стварни датум почетка студије: | 10/31/2016 |
| Процењени датум примарног завршетка: | 08/31/2019 |
| Предвиђени датум завршетка студије: | 08/31/2019 |
Стање или болест
Интервенција / лечење
Drug: risperidone with clozapine
Drug: aripiprazole with clozapine
Drug: sodium valproate with clozapine
Device: Modified electroconvulsive therapy with clozapine
Device: Magnetic seizure therapy with clozapine
Device: clozapine
Фаза
Групе руку
| Арм | Интервенција / лечење |
|---|---|
| Active Comparator: risperidone with clozapine risperidone, dosage form: 1 mg, dosage and frequency:3.0~6.0 mg/d; clozapine, dosage and frequency:300~600 mg/d; duration: 8 weeks | Drug: risperidone with clozapine Risperidone may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia |
| Active Comparator: aripiprazole with clozapine aripiprazole, dosage form: 5 mg, dosage and frequency:15~30 mg/day; clozapine, dosage and frequency:300~600 mg/d; duration: 8 weeks | Drug: aripiprazole with clozapine Aripiprazole may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia |
| Active Comparator: sodium valproate with clozapine sodium valproate, dosage form: 250 mg, dosage and frequency:600~1200 mg/day; clozapine, dosage and frequency:300~600 mg/d; duration: 3 months. | Drug: sodium valproate with clozapine sodium valproate may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia |
| Active Comparator: clozapine only clozapine, dosage and frequency:300~600 mg/d; | Device: clozapine clozapine may be used in the treatment of treatment-resistant schizophrenia |
| Active Comparator: Modified electroconvulsive therapy with clozapine 10 times MECT for 4 weeks, if the PANSS reductive ratio is less 20% in the end of 8th week by the using of risperidone with clozapine, aripiprazole with clozapine, sodium valproate with clozapine, or clozapine. | Device: Modified electroconvulsive therapy with clozapine modified electroconvulsive therapy(MECT) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia |
| Active Comparator: Magnetic seizure therapy with clozapine 10 times MST for 4 weeks, if the PANSS reductive ratio is less 20% in the end of 8th week by the using of risperidone with clozapine, aripiprazole with clozapine, sodium valproate with clozapine, or clozapine. | Device: Magnetic seizure therapy with clozapine Magnetic seizure therapy(MST) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia |
Критеријуми
| Узраст подобан за студирање | 18 Years До 18 Years |
| Полови подобни за студирање | All |
| Прихвата здраве волонтере | да |
| Критеријуми | Inclusion Criteria: - The diagnosis of schizophrenia according to DSM-V - 18～60 years old - 2 prior failed treatment trials with 2 different antipsychotics at doses of at least 600 mg/day chlorpromazine equivalents, each of at least 6 weeks duration; - Signed an informed consent Exclusion Criteria: - patients to be diagnosed according to DSM-V for substance abused, development delayed - suffering from serious physical disease and can not accept the treatment - MST contraindications: intracranial metal substance, with heart pacemakers and cochlear implants, intracranial pressure - allergic to risperidone ,aripiprazole, or sodium valproate - Participated in any clinical subject within 30 days - Pregnancy or lactation |
Исход
Примарне мере исхода
1. Change from baseline in Positive and Negative Syndrome Scale [PANSS] [At baseline, 4th week, 8th week,12th week]
Секундарне мере исхода
1. Change from baseline in clinical global impression [CGI] [At baseline, 4th week, 8th week,12th week]
2. Change from baseline in Simpson-Angus Scale [SAS] [At baseline, 4th week, 8th week,12th week]
3. Change from baseline in Abnormal Involuntary Movement Scale[AIMS] [At baseline, 4th week, 8th week,12th week]
