UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041321 |
|---|---|
| Receipt number | R000047185 |
| Scientific Title | Lemborexant for insomnia in patients with psychiatric disorder: A 1-week, open-label study |
| Date of disclosure of the study information | 2020/08/05 |
| Last modified on | 2020/08/05 15:26:00 |
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Basic information
Public title
Lemborexant for insomnia in patients with psychiatric disorder: A 1-week, open-label study
Acronym
Lemborexant for insomnia in patients with psychiatric disorder
Scientific Title
Lemborexant for insomnia in patients with psychiatric disorder: A 1-week, open-label study
Scientific Title:Acronym
Lemborexant for insomnia in patients with psychiatric disorder
Region
| Japan |
Condition
Condition
Insomnia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of lemborexant for insomnia in people with psychiatric disorders
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Time to sleep onset, total sleep time, wake time after sleep onset
Key secondary outcomes
Subjects' reported sleep satisfaction level, and the severity of their psychiatric disorder, discontinuation rate, incidence of individual adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lemborexant
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
It will include both female and male outpatients (aged 20 or more than 20 years) who attend the Department of Psychiatry in Fujita Health University Hospital and who experience any of the following insomnia symptoms for four or more nights during the week before they started the study: total sleep time (TST): 6 hours, time to sleep onset (TSO): 30 or more than 30 minutes, or two or more episodes of wake after sleep onset.
Key exclusion criteria
The following exclusion criteria will be applied: taking any sleeping pills other than ramelteon, zolpidem, zopiclone, or eszopiclone at baseline; contraindication to suvorexant; patients with coma; addiction to psychostimulants or alcohol; pregnancy or breastfeeding; neurological or systemic diseases; and anyone considered inappropriate to participate by the attending physician. We will not include any patient who received benzodiazepines before the study because sleeping pills other than the Z drugs (zolpidem, zopiclone, or eszopiclone) or ramelteon.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Kishi |
Organization
Fujita Health University School of Medicine
Division name
Psychiatry
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake
TEL
0562939250
tarok@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Kishi |
Organization
Fujita Health University School of Medicine
Division name
Psychiatry
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake
TEL
0562939250
Homepage URL
https://www.fujita-hu.ac.jp/~psychi/html/sinryo.html
tarok@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Research Ethics Committee
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake
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
| 2020 | Year | 08 | Month | 05 | 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
| 2020 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2020 | Year | 08 | Month | 05 | Day |
Last modified on
| 2020 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047185
