UMIN試験ID | UMIN000015709 |
---|---|
受付番号 | R000018264 |
科学的試験名 | Efficacy and Safety of Yokukansan in Schizophrenia: A Randomized, Multi-center, Double-Blind, Placebo-Controlled Trial |
一般公開日(本登録希望日) | 2014/11/25 |
最終更新日 | 2014/11/17 18:36:30 |
日本語
Efficacy and Safety of Yokukansan in Schizophrenia:
A Randomized, Multi-center, Double-Blind, Placebo-Controlled Trial
英語
Efficacy and Safety of Yokukansan in Schizophrenia:
A Randomized, Multi-center, Double-Blind, Placebo-Controlled Trial
日本語
Yokukansan for Schizophrenia
英語
Yokukansan for Schizophrenia
日本語
Efficacy and Safety of Yokukansan in Schizophrenia:
A Randomized, Multi-center, Double-Blind, Placebo-Controlled Trial
英語
Efficacy and Safety of Yokukansan in Schizophrenia:
A Randomized, Multi-center, Double-Blind, Placebo-Controlled Trial
日本語
Yokukansan for Schizophrenia
英語
Yokukansan for Schizophrenia
日本/Japan |
日本語
Schizophrenia
英語
Schizophrenia
精神神経科学/Psychiatry |
悪性腫瘍以外/Others
いいえ/NO
日本語
This study aimed to evaluate the efficacy and tolerability of TJ-54 as an add-on pharmacotherapy for clinical symptoms in patients with schizophrenia over a 12-week period.
英語
This study aimed to evaluate the efficacy and tolerability of TJ-54 as an add-on pharmacotherapy for clinical symptoms in patients with schizophrenia over a 12-week period.
安全性・有効性/Safety,Efficacy
日本語
英語
日本語
Positive and Negative Syndrome Scale
英語
Positive and Negative Syndrome Scale
日本語
英語
介入/Interventional
並行群間比較/Parallel
ランダム化/Randomized
個別/Individual
二重盲検/Double blind -all involved are blinded
プラセボ・シャム対照/Placebo
いいえ/NO
はい/YES
動的割付けの際に施設を調整因子としている/Institution is considered as adjustment factor in dynamic allocation.
いいえ/NO
中央登録/Central registration
2
治療・ケア/Treatment
医薬品/Medicine |
日本語
Yokukansan
英語
Yokukansan
日本語
Placebo
英語
Placebo
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
18 | 歳/years-old | 以上/<= |
70 | 歳/years-old | 以下/>= |
男女両方/Male and Female
日本語
Male or female hospitalized patients were eligible for inclusion in the study if they met all of the following criteria: age of 20-59 years; a primary Diagnostic and Statistical Manual of Mental Disorders, 4th edn, text revision diagnosis of schizophrenia, established by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, with a length of at least 3 years; history of documented treatment-resistant status, which is defined as the absence of clinically significant improvement after treatment with at least 2 neuroleptics for 6 weeks or longer after receiving a full dose equivalent to 600 mg/day of chlorpromazine; presence of persistent positive symptoms as evident by a score of at least 10 on the positive symptom subscale of the Positive and Negative Syndrome Scale; and an overall score of at least 60 on the PANSS on the Clinical Global Impression-Severity.
英語
Male or female hospitalized patients were eligible for inclusion in the study if they met all of the following criteria: a primary Diagnostic and Statistical Manual of Mental Disorders, 4th edn, text revision diagnosis of schizophrenia, established by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, with a length of at least 3 years; history of documented treatment-resistant status, which is defined as the absence of clinically significant improvement after treatment with at least 2 neuroleptics for 6 weeks or longer after receiving a full dose equivalent to 600 mg/day of chlorpromazine; presence of persistent positive symptoms as evident by a score of at least 10 on the positive symptom subscale of the Positive and Negative Syndrome Scale; and an overall score of at least 60 on the PANSS on the Clinical Global Impression-Severity.
日本語
Exclusion criteria included pregnancy, lactation, other clinical significant or unstable conditions, and history of alcohol or substance abuse in the last 6 months. No patients had been treated by clozapine in this clinical trial. Because the clozapine has not been available in Japan until 2009, therefore it might have been difficult to include patients who had gone clozapine trial in the past.
英語
Exclusion criteria included pregnancy, lactation, other clinical significant or unstable conditions, and history of alcohol or substance abuse in the last 6 months. No patients had been treated by clozapine in this clinical trial. Because the clozapine has not been available in Japan until 2009, therefore it might have been difficult to include patients who had gone clozapine trial in the past.
60
日本語
名 | |
ミドルネーム | |
姓 | Tsuyoshi Miyaoka |
英語
名 | |
ミドルネーム | |
姓 | Tsuyoshi Miyaoka |
日本語
Shimane University School of Medicine
英語
Shimane University School of Medicine
日本語
Psychiatry
英語
Psychiatry
日本語
Enyacho 89-1, Izumo
英語
Enyacho 89-1, Izumo
0853-20-2262
miyanyan@med.shimane-u.ac.jp
日本語
名 | |
ミドルネーム | |
姓 | Sakura Hino |
英語
名 | |
ミドルネーム | |
姓 | Sakura Hino |
日本語
Shimane University School of Medicine
英語
Shimane University School of Medicine
日本語
Psychiatry
英語
Psychiatry
日本語
Enyacho 89-1, Izumo
英語
Enyacho 89-1, Izumo
0853-20-2262
saku4444@med.shimane-u.ac.jp
日本語
その他
英語
Shimane University School of Medicine
日本語
Shimane University School of Medicine
日本語
日本語
英語
日本語
その他
英語
The Waksman Foundation of Japan INC
日本語
The Waksman Foundation of Japan INC
日本語
財団/Non profit foundation
日本語
Japan
英語
Japan
日本語
英語
日本語
英語
日本語
英語
日本語
英語
いいえ/NO
日本語
英語
日本語
英語
Shimane University School of Medicine
2014 | 年 | 11 | 月 | 25 | 日 |
未公表/Unpublished
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
一般募集中/Open public recruiting
2014 | 年 | 09 | 月 | 17 | 日 |
2014 | 年 | 10 | 月 | 25 | 日 |
日本語
英語
2014 | 年 | 11 | 月 | 17 | 日 |
2014 | 年 | 11 | 月 | 17 | 日 |
日本語
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000018264
英語
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018264
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