UMIN-CTR Clinical Trial

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