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利用者名:
UMIN ID:

試験進捗状況 一般募集中/Open public recruiting
UMIN試験ID UMIN000023581
受付番号 R000027142
科学的試験名
一般公開日(本登録希望日) 2018/12/31
最終更新日 2020/08/17

※ 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
Maintaining the antidepressant effect with D-cycloserine, a NMDA receptor partial agonist, following acute ketamine infusion for treatment resistant depression: A randomized double-blind placebo-controlled study
一般向け試験名略称/Acronym
Maintaining the antidepressant effect with D-cycloserine, a NMDA receptor partial agonist, following acute ketamine infusion for treatment resistant depression: A randomized double-blind placebo-controlled study
科学的試験名/Scientific Title
Maintaining the antidepressant effect with D-cycloserine, a NMDA receptor partial agonist, following acute ketamine infusion for treatment resistant depression: A randomized double-blind placebo-controlled study
科学的試験名略称/Scientific Title:Acronym
Maintaining the antidepressant effect with D-cycloserine, a NMDA receptor partial agonist, following acute ketamine infusion for treatment resistant depression: A randomized double-blind placebo-controlled study
試験実施地域/Region
アジア(日本以外)/Asia(except Japan)

対象疾患/Condition
対象疾患名/Condition
Treating Major 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
1) To assess the maintaining antidepressant effect of D-cycloserine (DCS) and its ability to prevent relapse of depression (i.e., increase of MADRS depression score vs. baseline >= 30%).
2) To evaluate the clinical efficacy of two repeated ketamine infusions on TRD patients within one week.
3) To search for variant of BDNF polymorphism, BDNF & glycine levels and cytokines to be biomarker for predicting clinical response.
4) To find the correlation of changes of brain imaging with ketamine or DCS with antidepressant effect, thereby explore the neurocircuitry related to treatment with glutamate-related agents.
目的2/Basic objectives2 有効性/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
To assess the maintaining antidepressant effect of D-cycloserine (DCS) on responders of ketamine infusion by comparing the relapse rates of treatment (D-cycloserine) and placebo group in Stage II. Relapse is defined as two consecutive nonresponses (MADRS depression score is 30% higher than Baseline of Stage II).The difference between two relapse rates larger than 30% will be regarded as efficacy.
副次アウトカム評価項目/Key secondary outcomes
1) To evaluate the clinical efficacy of two repeated ketamine infusions on TRD patients within one week.
2) To search for variant of BDNF polymorphism, BDNF & glycine levels and cytokines to be biomarker for predicting clinical response.
3) To find the correlation of changes of brain imaging with ketamine or DCS with antidepressant effect, thereby explore the neurocircuitry related to treatment with glutamate-related agents.
4) To use EEG biomarkers, i.e., normalization of left - right ratio of brain waves following ketamine infusion, to predict better response to DCS treatment.

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 ランダム化/Randomized
ランダム化の単位/Randomization unit 集団/Cluster
ブラインド化/Blinding 二重盲検/Double blind -all involved are blinded
コントロール/Control プラセボ・シャム対照/Placebo
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
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
DCS
介入2/Interventions/Control_2
PLACEBO
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
65 歳/years-old 未満/>
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
1.Major depression including unipolar and bipolar depression.
2.Age>=20y/o<65 y/o
3.Treatment resistant depression was defined as the depressed subjects failed to respond to at least two antidepressants with their optimal dose and over four week treatment in previous medication history.
4.Patient on stabilized background medications.
5.moderate to severe depressive symptoms (MADRS>=25, HAMD-17>=18)


除外基準/Key exclusion criteria
1.Major medical conditions.
2.Other axis I psychiatric disorders such as schizophrenia, delusional disorder, organic brain syndrome, and dementia.
3.Pregnancy or lactation
4.Hypersensitive to D-cycloserine and Ketamine
5.Substance abuse in previous 6 months such as cocaine, marijuana, opium, ketamine, PCP (phencyclidine).
6.Current use of NMDA receptor antagonist (Amantadine, Rimantadine, Lamotrigine, Memantine, Dextromethorphan).
7.Alcohol abuse / dependence within 6 months.
8.Attempt suicide in hospital.
9.Risk for current homicidal tendency.
目標参加者数/Target sample size 90

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

ミドルネーム

Tung Ping
ミドルネーム
Su
所属組織/Organization
Taipei Veterans General Hospital
所属部署/Division name
Psychiatry
郵便番号/Zip code 112
住所/Address
No.201, Sec.2, Shih-Pai Road, Beitou district
電話/TEL +886-2-28757778
Email/Email ju.orangesea@gmail.com

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

Tung Ping
ミドルネーム
Su
組織名/Organization
Taipei Veterans General Hospital
部署名/Division name
Psychiatry
郵便番号/Zip code 112
住所/Address
No.201, Sec.2, Shih-Pai Road, Beitou district
電話/TEL +886-2-28757778
試験のホームページURL/Homepage URL
Email/Email tomsu0402@gmail.com

実施責任組織/Sponsor
機関名/Institute その他 Ministry of Science and Technology
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Ministry of Science and Technology
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 海外/Outside Japan
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
Taipei Veterans General Hospital, Taiwan
住所/Address
No.201, Sec.2, Shih-Pai Rd, Beitou district, Taipei, Taiwan
電話/Tel 886-2-28757384
Email/Email slchang@vghtpe.gov.tw

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

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
2018 12 31

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 一般募集中/Open public recruiting
プロトコル確定日/Date of protocol fixation
2015 01 01
倫理委員会による承認日/Date of IRB
2014 07 14
登録・組入れ開始(予定)日/Anticipated trial start date
2015 08 01
フォロー終了(予定)日/Last follow-up date
2017 12 22
入力終了(予定)日/Date of closure to data entry
2018 03 31
データ固定(予定)日/Date trial data considered complete
2018 05 30
解析終了(予定)日/Date analysis concluded
2018 08 07

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
2016 08 10
最終更新日/Last modified on
2020 08 17


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=R000027142
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027142

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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