UMIN試験ID | UMIN000028341 |
---|---|
受付番号 | R000032439 |
科学的試験名 | Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder: A Prospective, Open-Label Trial |
一般公開日(本登録希望日) | 2019/07/23 |
最終更新日 | 2017/07/23 20:48:04 |
日本語
Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder:
A Prospective, Open-Label Trial
英語
Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder:
A Prospective, Open-Label Trial
日本語
Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder
英語
Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder
日本語
Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder:
A Prospective, Open-Label Trial
英語
Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder:
A Prospective, Open-Label Trial
日本語
Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder
英語
Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder
日本/Japan |
日本語
treatment-resistant depression
英語
treatment-resistant depression
精神神経科学/Psychiatry |
悪性腫瘍以外/Others
いいえ/NO
日本語
We performed a prospective study to evaluate the effects of Clostridium butyricum MIYAIRI (CBM588)for treatment-resistant depression
英語
We performed a prospective study to evaluate the effects of Clostridium butyricum MIYAIRI (CBM588)for treatment-resistant depression
安全性・有効性/Safety,Efficacy
日本語
英語
日本語
The primary end point was the change from baseline in the Hamilton Depression Rating Scale (HAM-D-17) score from baseline to week 8.
英語
The primary end point was the change from baseline in the Hamilton Depression Rating Scale (HAM-D-17) score from baseline to week 8.
日本語
Secondary end points were changes in Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI) Scale scores from baseline to week 8.
英語
Secondary end points were changes in Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI) Scale scores from baseline to week 8.
介入/Interventional
並行群間比較/Parallel
非ランダム化/Non-randomized
オープンだが測定者がブラインド化されている/Open -but assessor(s) are blinded
無治療対照/No treatment
いいえ/NO
いいえ/NO
施設を考慮していない/Institution is not considered as adjustment factor.
いいえ/NO
知る必要がない/No need to know
2
治療・ケア/Treatment
医薬品/Medicine |
日本語
Clostridium butyricum MIYAIRI (CBM588)
英語
Clostridium butyricum MIYAIRI (CBM588)
日本語
This study was a 8-week, prospective open-label evaluation of CBM588 (60 mg/day) in patients with TRD.
英語
This study was a 8-week, prospective open-label evaluation of CBM588 (60 mg/day) in patients with TRD.
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
20 | 歳/years-old | 以上/<= |
70 | 歳/years-old | 以下/>= |
男女両方/Male and Female
日本語
Twenty patients experiencing symptom of TRD were enrolled in this study according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) (American Psychiatry Association 2000). TRD was based on chart reviews and defined as an inadequate or nonresponse to 2 or more 8-week trials with 2 different classes of antidepressants. For at least 3 of these 8 weeks, doses were required to be at or near the highest recommended therapeutic dose. Patients with a 17-item Hamiliton Rating Scale Depression (HAMD-17) (Zheng et al., 1988) total score of 16 or greater at the end of screening phase were eligible to participate in this study.
英語
Twenty patients experiencing symptom of TRD were enrolled in this study according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) (American Psychiatry Association 2000). TRD was based on chart reviews and defined as an inadequate or nonresponse to 2 or more 8-week trials with 2 different classes of antidepressants. For at least 3 of these 8 weeks, doses were required to be at or near the highest recommended therapeutic dose. Patients with a 17-item Hamiliton Rating Scale Depression (HAMD-17) (Zheng et al., 1988) total score of 16 or greater at the end of screening phase were eligible to participate in this study.
日本語
Patients were excluded if they met criteria for an Axis I diagnosis of delirium, dementia or other cognitive disorder, bipolar disorder, schizophrenia or other psychotic disorder, or a clinically significant Axis II diagnosis of obsessive-compulsive, schizoid, schizotypal, paranoid, antisocial, or histrionic personality disorder. Patients were also excluded if they acknowledged substance abuse or dependence within the past 6 months, or if they were pregnant, were nursing, or posed a significant risk of suicide during the study period. Patients with chronic deteriorating illnesses such as diabetes, HIV, and seizure disorders were also excluded.
英語
Patients were excluded if they met criteria for an Axis I diagnosis of delirium, dementia or other cognitive disorder, bipolar disorder, schizophrenia or other psychotic disorder, or a clinically significant Axis II diagnosis of obsessive-compulsive, schizoid, schizotypal, paranoid, antisocial, or histrionic personality disorder. Patients were also excluded if they acknowledged substance abuse or dependence within the past 6 months, or if they were pregnant, were nursing, or posed a significant risk of suicide during the study period. Patients with chronic deteriorating illnesses such as diabetes, HIV, and seizure disorders were also excluded.
25
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
Department of Psychiatry,
英語
Department of Psychiatry,
日本語
89-1 Enyacho, Izumo 693-8501
英語
89-1 Enyacho, Izumo 693-8501
853-20-2262
miyanyan@med.shimane-u.ac.jp
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
Department of Psychiatry
英語
Department of Psychiatry
日本語
89-1 Enyacho, Izumo 693-8501
英語
89-1 Enyacho, Izumo 693-8501
853-20-2262
miyanyan@med.shimane-u.ac.jp
日本語
その他
英語
Shimane University School of Medicine
日本語
島根大学医学部精神医学講座
日本語
日本語
英語
日本語
無し
英語
no grant
日本語
日本語
自己調達/Self funding
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
いいえ/NO
日本語
英語
日本語
英語
島根大学医学部
2019 | 年 | 07 | 月 | 23 | 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
参加者募集中断/Suspended
2018 | 年 | 12 | 月 | 15 | 日 |
2019 | 年 | 04 | 月 | 01 | 日 |
日本語
英語
2017 | 年 | 07 | 月 | 23 | 日 |
2017 | 年 | 07 | 月 | 23 | 日 |
日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000032439
英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032439
研究計画書 | |
---|---|
登録日時 | ファイル名 |
研究症例データ仕様書 | |
---|---|
登録日時 | ファイル名 |
研究症例データ | |
---|---|
登録日時 | ファイル名 |