UMIN-CTR Clinical Trial

Basic information
Public title	The Effects of Benzodiazepine and Orexin Receptor Antagonist on Cognitive Function Revealed by Auditory Event-related Potentials
Acronym	ERPs reflect BZ and suvorexant effects on cognition
Scientific Title	The Effects of Benzodiazepine and Orexin Receptor Antagonist on Cognitive Function Revealed by Auditory Event-related Potentials
Scientific Title:Acronym	ERPs reflect BZ and suvorexant effects on cognition
Region	Japan

Condition
Condition	Insomnia
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to estimate the cognitive decline 1 day after oral medication with lormetazepam, a benzodiazepine, and suvorexant, an orexin receptor antagonist, by comparing mismatch negativity (MMN) and P300 reflecting auditory discrimination function.
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Individual mean amplitudes of mismatch negativity (MMN) and P300 1 day after oral administration of lormetazapam and suvorexant.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Receiving suvorexant 20 mg
Interventions/Control_2	Receiving lormetazepam 2 mg
Interventions/Control_3	Receiving placebo
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	Healthy participants aged 20 years and older
Key exclusion criteria	History of mental illness and neurological disorder
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Tetsuyta Middle name Last name Shiga
Organization	Fukushima Medical University
Division name	Department of Neuropsychiatry
Zip code	960-1295
Address	Hikarigaoka 1, Fukushima
TEL	024-547-1331
Email	tetsuya3@fmu.ac.jp

Public contact
Name of contact person	1st name Tetsuya Middle name Last name Shiga
Organization	Fukushima Medical University
Division name	Department of Neuropsychiatry
Zip code	960-1295
Address	Hikarigaoka 1, Fukushima
TEL	024-547-1331
Homepage URL
Email	tetsuya3@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University
Institute
Department

Funding Source
Organization	Fukushima Medical 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	Ethics Committee of Fukushima Medical University
Address	Hikarigaoka 1, Fukushima
Tel	024-547-1111
Email	rs@fmu.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	2019 Year 07 Month 15 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	60
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	Completed
Date of protocol fixation	2016 Year 01 Month 01 Day
Date of IRB	2016 Year 01 Month 19 Day
Anticipated trial start date	2016 Year 02 Month 01 Day
Last follow-up date	2019 Year 01 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	2019 Year 07 Month 13 Day
Last modified on	2019 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042600