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利用者名:
UMIN ID:

試験進捗状況 参加者募集中断/Suspended
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

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder:
A Prospective, Open-Label Trial
Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder:
A Prospective, Open-Label Trial
一般向け試験名略称/Acronym Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder
Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder
科学的試験名/Scientific Title Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder:
A Prospective, Open-Label Trial
Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder:
A Prospective, Open-Label Trial
科学的試験名略称/Scientific Title:Acronym Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder
Clostridium butyricum MIYAIRI (CBM588) as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition treatment-resistant depression treatment-resistant depression
疾患区分1/Classification by specialty
精神神経科学/Psychiatry
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1 We performed a prospective study to evaluate the effects of Clostridium butyricum MIYAIRI (CBM588)for treatment-resistant depression We performed a prospective study to evaluate the effects of Clostridium butyricum MIYAIRI (CBM588)for treatment-resistant depression
目的2/Basic objectives2 安全性・有効性/Safety,Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes The primary end point was the change from baseline in the Hamilton Depression Rating Scale (HAM-D-17) score from baseline to week 8. The primary end point was the change from baseline in the Hamilton Depression Rating Scale (HAM-D-17) score from baseline to week 8.
副次アウトカム評価項目/Key secondary outcomes Secondary end points were changes in Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI) Scale scores from baseline to week 8. Secondary end points were changes in Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI) Scale scores from baseline to week 8.

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization 非ランダム化/Non-randomized
ランダム化の単位/Randomization unit
ブラインド化/Blinding 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
コントロール/Control 無治療対照/No treatment
層別化/Stratification いいえ/NO
動的割付/Dynamic allocation いいえ/NO
試験実施施設の考慮/Institution consideration 施設を考慮していない/Institution is not considered as adjustment factor.
ブロック化/Blocking いいえ/NO
割付コードを知る方法/Concealment 知る必要がない/No need to know

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
医薬品/Medicine
介入1/Interventions/Control_1 Clostridium butyricum MIYAIRI (CBM588)


Clostridium butyricum MIYAIRI (CBM588)
介入2/Interventions/Control_2 This study was a 8-week, prospective open-label evaluation of CBM588 (60 mg/day) in patients with TRD. This study was a 8-week, prospective open-label evaluation of CBM588 (60 mg/day) in patients with TRD.
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
20 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
70 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria 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. 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.
除外基準/Key exclusion criteria 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. 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.
目標参加者数/Target sample size 25

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム
Tsuyoshi Miyaoka

ミドルネーム
Tsuyoshi Miyaoka
所属組織/Organization Shimane University School of Medicine Shimane University School of Medicine
所属部署/Division name Department of Psychiatry, Department of Psychiatry,
郵便番号/Zip code
住所/Address 89-1 Enyacho, Izumo 693-8501 89-1 Enyacho, Izumo 693-8501
電話/TEL 853-20-2262
Email/Email miyanyan@med.shimane-u.ac.jp

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム
Tsuyoshi Miyaoka

ミドルネーム
Tsuyoshi Miyaoka
組織名/Organization Shimane University School of Medicine Shimane University School of Medicine
部署名/Division name Department of Psychiatry Department of Psychiatry
郵便番号/Zip code
住所/Address 89-1 Enyacho, Izumo 693-8501 89-1 Enyacho, Izumo 693-8501
電話/TEL 853-20-2262
試験のホームページURL/Homepage URL
Email/Email miyanyan@med.shimane-u.ac.jp

実施責任組織/Sponsor
機関名/Institute その他 Shimane University School of Medicine
機関名/Institute
(機関選択不可の場合)
島根大学医学部精神医学講座
部署名/Department

研究費提供組織/Funding Source
機関名/Organization 無し no grant
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 自己調達/Self funding
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization

住所/Address

電話/Tel
Email/Email

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions 島根大学医学部

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2019 07 23

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/Results

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 参加者募集中断/Suspended
プロトコル確定日/Date of protocol fixation
2018 12 15
倫理委員会による承認日/Date of IRB
登録・組入れ開始(予定)日/Anticipated trial start date
2019 04 01
フォロー終了(予定)日/Last follow-up date
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2017 07 23
最終更新日/Last modified on
2017 07 23


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000032439
URL(英語) https://upload.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


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