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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004381
Receipt No. R000005236
Scientific Title fMRI study on effect of NK1 antagonist (Aprepitant) on cognitive function in normal subjects
Date of disclosure of the study information 2010/10/14
Last modified on 2019/07/26

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Basic information
Public title fMRI study on effect of NK1 antagonist (Aprepitant) on cognitive function in normal subjects
Acronym fMRI study on effect of NK1 antagonist (Aprepitant) on cognitive function in normal subjects
Scientific Title fMRI study on effect of NK1 antagonist (Aprepitant) on cognitive function in normal subjects
Scientific Title:Acronym fMRI study on effect of NK1 antagonist (Aprepitant) on cognitive function in normal subjects
Region
Japan

Condition
Condition Substance-related disorders, Mood disorders, Anxiety disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the effect of NK1 antagonist (Aprepitant) on human cognitive function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Comparison between placebo and Aprepitant conditions.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1day 1 time Aprepitant 125mg
washout duration 1 week
1day 1 time placebo (lactose)
Interventions/Control_2 1day 1 time placebo (lactose)
washout duration 1 week
1day 1 time Aprepitant 125mg
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
40 years-old >
Gender Male and Female
Key inclusion criteria healthy adult
Key exclusion criteria patients with psychiatric disorder
patients with hepatic, kidney, cardiac disorders
patients taking other drugs
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hidenori
Middle name
Last name Suzuki
Organization Nippon Medical School
Division name Pharmacology
Zip code 113-8602
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8602, Japan
TEL 03-3822-2131
Email hsuzuki@nms.ac.jp

Public contact
Name of contact person
1st name Yumiko
Middle name
Last name Ikeda
Organization Nippon Medical School
Division name Pharmacology
Zip code 113-8602
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8602, Japan
TEL 03-3822-2131
Homepage URL
Email y-ikeda@nms.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Research Promotion Department, Nippon Medical School
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8602, Japan
Tel 03-3822-2131
Email clinicaltrial@nms.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 06 Month 18 Day
Date of IRB
2010 Year 06 Month 18 Day
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
2011 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 10 Month 13 Day
Last modified on
2019 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005236

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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