UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041321
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email tarok@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047185

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.