UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049310 |
|---|---|
| Receipt number | R000056156 |
| Scientific Title | Effects of Lemborexant on insomnia in patients with schizophrenia : A randomized controlled study |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2023/05/17 09:46:59 |
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Basic information
Public title
Effects of Lemborexant on insomnia in patients with schizophrenia
: A randomized controlled study
Acronym
Effects of Lemborexant on insomnia in patients with schizophrenia
: A randomized controlled study
Scientific Title
Effects of Lemborexant on insomnia in patients with schizophrenia
: A randomized controlled study
Scientific Title:Acronym
Effects of Lemborexant on insomnia in patients with schizophrenia
: A randomized controlled study
Region
| Japan |
Condition
Condition
Insomnia in patients with schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To objectively investigate the effect of Lemborexant on insomnia in schizophrenic patients.
Basic objectives2
Others
Basic objectives -Others
To evaluate the association between nighttime blood orexin A levels and the efficacy of Lenvorexant
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Sleep variables obtained from actigraphs. Comparison between the 7-day pre-observation period and the 7th to 13th days after the intervention.
Key secondary outcomes
Association between change from baseline in sleep variables obtained from Actigraphs and blood orexin A levels at night.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of 5 mg of Lemborexant for 14 days
Interventions/Control_2
14 days of placebo administration
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Satisfy DSM5 diagnostic criteria for schizophrenia
2. Being treated in Kurita hospital
3.Those aged between 20 and 70.
4.Satisfy DSM5 diagnostic criteria for insomnia.
5.Using one or less benzodiazepines.
6.Not taking orexin receptor antagonists.
Key exclusion criteria
1.Coexisting with mood disorder, anxiety disorder, drug addiction, or personality disorder.
2.Suffering from serious physical diseases such as cerebrovascular disease, heart disease, renal dysfunction, and neurological disease.
3.Coexisting with other sleep disorders such as hypersomnia, sleep-related breathing disorders, circadian rhythm sleep disorders, parasomnia, and sleep-related movement disorders.
4.Actigraphy cannot be performed safely.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Arai |
Organization
Shinshu University School of Medicine
Division name
Department of Psychiatry
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto-City, Nagano, Japan,
TEL
+81-263-37-2638
y-arai@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Arai |
Organization
Kurita Hospital
Division name
Department of Psychiatry
Zip code
380-0921
Address
695 Kurita Nagano-City Nagano, Japan, 380-0921
TEL
+81-262-26-1311
Homepage URL
y-arai@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Kurita Hospital, 695 Kurita Nagano-City Nagano, Japan, 380-0921
Institute
Department
Personal name
Funding Source
Organization
Department of Psychiatry, Kurita Hospital, 695 Kurita Nagano-City Nagano, Japan, 380-0921
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Psychiatry, Kurita Hospital
Address
695 Kurita Nagano-City Nagano, Japan, 380-0921
Tel
+81-262-26-1311
19hm101k@shinshu-u.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
栗田病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 01 | 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
0
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
Terminated
Date of protocol fixation
| 2022 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 10 | Month | 25 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056156
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/04/29 | 症例登録票.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/04/29 | 症例報告.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
