UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037363 |
|---|---|
| Receipt number | R000042600 |
| Scientific Title | The Effects of Benzodiazepine and Orexin Receptor Antagonist on Cognitive Function Revealed by Auditory Event-related Potentials |
| Date of disclosure of the study information | 2019/07/15 |
| Last modified on | 2019/07/13 15:49:01 |
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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
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
tetsuya3@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042600
