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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024842
Receipt No. R000028588
Scientific Title Effects of dl-methylephedrine on cognitive functions in normal adults using fMRI: randomized, placebo-controlled, double-blind, comparative study
Date of disclosure of the study information 2016/11/15
Last modified on 2016/11/15

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Basic information
Public title Effects of dl-methylephedrine on cognitive functions in normal adults using fMRI: randomized, placebo-controlled, double-blind, comparative study
Acronym Effects of dl-methylephedrine on cognitive functions in normal adults using fMRI: randomized, placebo-controlled, double-blind, comparative study
Scientific Title Effects of dl-methylephedrine on cognitive functions in normal adults using fMRI: randomized, placebo-controlled, double-blind, comparative study
Scientific Title:Acronym Effects of dl-methylephedrine on cognitive functions in normal adults using fMRI: randomized, placebo-controlled, double-blind, comparative study
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the effects of dl-methylephedrine on human cognitive functions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes BOLD signal changes measured by fMRI
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 1 day, 1 time, dl-methylephedrine 60mg
washout duration 1 week
1 day, 1 time, placebo
Interventions/Control_2 1 day, 1 time, placebo
washout duration 1 week
1 day, 1 time, dl-methylephedrine 60mg
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 Subjects with no history of psychiatric disorders.
Subjects with normal BMI (18.5-25)
Subjects who have the ability to provide informed consent and adhere to the protocol.
Key exclusion criteria Subjects with drug allergy.
Subjects taking drugs within 2 weeks of the trial.
Subjects with hyperthyroidism, hypertension, heart disease, diabetes, severe asthma or hypoxemia.
Pregnant woman, woman suspected of being pregnant, or lactating woman.
Subject who is contraindicated for the use of MRI.
Subjects taking caffeine 2 days before or alcohol the day before the trial.
Subjects who are judged as not suitable for participation in this study.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiro Okubo
Organization Nippon Medical School
Division name Department of Neuropsychiatry
Zip code
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL 03-3822-2131
Email okubo-y@nms.ac.jp

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

Sponsor
Institute Nippon Medical School
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 11 Month 15 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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 15 Day
Last modified on
2016 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028588

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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