UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024842 |
|---|---|
| Receipt number | 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 | 2020/05/22 09:37:06 |
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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 | Yoshiro |
| Middle name | |
| Last name | Okubo |
Organization
Nippon Medical School
Division name
Department of Neuropsychiatry
Zip code
113-8602
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
okubo-y@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | Ikeda |
Organization
Nippon Medical School
Division name
Department of Pharmacology
Zip code
113-8602
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
Homepage URL
y-ikeda@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
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
Nippon Medical School Hospital IRB
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
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
| 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
29
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 15 | Day |
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
| 2020 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028588
