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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024228
Receipt No. 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 2019/05/02

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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
Email 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
Email tsuyoshi@fujita-hu.ac.jp

Sponsor
Institute FUJITA HEALTH UNIVERSITY
Institute
Department

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
Email 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
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
2019 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027218

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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