The Optimal Treatment for Treatment-resistant Schizophrenia
キーワード
概要
説明
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.
日付
| 最終確認済み: | 09/30/2017 |
| 最初に提出された: | 10/04/2016 |
| 提出された推定登録数: | 10/04/2016 |
| 最初の投稿: | 10/05/2016 |
| 最終更新が送信されました: | 03/10/2019 |
| 最終更新日: | 03/12/2019 |
| 実際の研究開始日: | 10/31/2016 |
| 一次完了予定日: | 08/31/2019 |
| 研究完了予定日: | 08/31/2019 |
状態または病気
介入/治療
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
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| 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 |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | 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 |
結果
主な結果の測定
1. Change from baseline in Positive and Negative Syndrome Scale [PANSS] [At baseline, 4th week, 8th week,12th week]
二次的な結果の測定
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]
