UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024228 |
|---|---|
| Receipt number | R000027218 |
| Scientific Title | A study of the effectiveness of small dose and early phase administration of ramelteon for delayed slepp phase disorder(DSPD) |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2020/03/17 15:49:03 |
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Basic information
Public title
A study of the effectiveness of small dose and early phase administration of ramelteon for delayed slepp phase disorder(DSPD)
Acronym
Small dose and early phase administration of ramelteon for DSPD
Scientific Title
A study of the effectiveness of small dose and early phase administration of ramelteon for delayed slepp phase disorder(DSPD)
Scientific Title:Acronym
Small dose and early phase administration of ramelteon for DSPD
Region
| Japan |
Condition
Condition
Delayed Sleep-Wake Sleep Disorder (Delayed Sleep Phase Disorder)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the effectiveness of small dose and early phase administration of ramelteon for DSPD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DLMO (Dim Light Melatonin Onset) after 4 weeks of ramelteon treatment
Key secondary outcomes
Sleep onset time, offset time, and total sleep time recorded by sleep diary and actigraph
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1)Ramelteon 1mg(5 consecutive weeks taking)
2)Measure of salivary melatonin concentration. (before treatment (pre-medication) and after treatment (post-dose 5 weeks))
Interventions/Control_2
1)placebo(5 consecutive weeks taking)
2)Measure of salivary melatonin concentration. (before treatment (pre-medication) and after treatment (post-dose 5 weeks))
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Outpatients with a diagnosis of delayed sleep-wake phase disorder(DSWPD)according to the International Classification of Sleep Disorders, 3rd edition(ICSD-3)
2)>= 15years old and having graduated from a junior highschool
3)Being able to provide informed consent
Key exclusion criteria
1)Using melatonin or ramelteon
2)Using psycotropic agents
3)judged inapropriate by a physician for some other reason
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | TSUYOSHI |
| Middle name | |
| Last name | KITAJIMA |
Organization
school of medicine
Division name
department of psychiatry
Zip code
470-1192
Address
1-98 Dengakugakubo,Kutsukake-cho,Toyoake, Aichi 470-1192,JAPAN
TEL
0562-93-9001
tsuyoshi@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | TSUYOSHI |
| Middle name | |
| Last name | KITAJIMA |
Organization
department of medicine
Division name
department of psychiatry
Zip code
470-1192
Address
1-98 Dengakugakubo,Kutsukake-cho,Toyoake, Aichi 470-1192,JAPAN
TEL
0562-93-9001
Homepage URL
tsuyoshi@fujita-hu.ac.jp
Sponsor or person
Institute
FUJITA HEALTH UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
FUJITA HEALTH UNIVERSITY
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Fujita Health University
Address
1-98 Dengakugakubo,Kutsukake-cho,Toyoake, Aichi 470-1192,JAPAN
Tel
0562-93-2865
f-irb@fujita-hu.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 | 10 | Month | 01 | 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
2
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
Terminated
Date of protocol fixation
| 2015 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | 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
| 2016 | Year | 09 | Month | 30 | Day |
Last modified on
| 2020 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027218
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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