UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049311 |
|---|---|
| Receipt number | R000056162 |
| Scientific Title | Effect of brexpiprazole on sleep architecture in patients with schizophrenia |
| Date of disclosure of the study information | 2022/10/25 |
| Last modified on | 2023/01/10 15:56:46 |
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Basic information
Public title
Effect of brexpiprazole on sleep architecture in patients with schizophrenia
Acronym
Effect of brexpiprazole on sleep architecture in patients with schizophrenia
Scientific Title
Effect of brexpiprazole on sleep architecture in patients with schizophrenia
Scientific Title:Acronym
Effect of brexpiprazole on sleep architecture in patients with schizophrenia
Region
| Japan |
Condition
Condition
Patients with schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate the effect of brexpiprazole on sleep variables measured by polysomnography in patients with schizophrenia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep variables measured by PSG: comparison before intervention and after 4 weeks of brexpiprazole administration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Add-on brexpiprazole for 4 weeks
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1, DSM-5 diagnosis of schizophrenia
2. Duration of illness over 20 years
3. Treatment with haloperidol alone for 1 month or more
Key exclusion criteria
1.Comorbidity with mood disorder, anxiety disorder, drug addiction, personality disorder
2.Comorbidity with serious physical diseases such as cerebrovascular disease, heart disease, renal dysfunction, neurological disease
2.Comorbidity with sleep disorders such as hypersomnia, sleep-related breathing disorders, circadian rhythm sleep disorders, parasomnias, and sleep-related movement disorders
3. Use of drugs that affect sleep electroencephalography (EEG), such as hypnotics, anxiolytics, mood stabilizers, antihistamines, steroids, etc.
4.Apnea Hypopnea Index (AHI) > 15/h; and Periodic Limb Movement Index (PLMI) > 15/h.
Target sample size
10
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, 390-8621
TEL
+81-263-37-2638
19hm101k@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
380-0823
Address
695 Kurita Nagano-City Nagano, Japan, 380-0921
TEL
+81-262-26-1311
Homepage URL
19hm101k@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Kurita Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Psychiatry, Kurita Hospital
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 | 10 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
7
Results
Add-on brexpiprazole had the following effects on sleep architecture in patients with schizophrenia.
The fraction of stage N2 increased by 14.0% (p = 0.018), and the duration increased by 49.9 min (p = 0.018). The fraction of stage N3 increased by 0.7% (p = 0.027), and the duration increased by 2.5 min (p = 0.034). Additionally, the fraction of stage REM sleep was reduced by 10.0% (p = 0.018), and the duration was decreased by 33.8 min (p = 0.018).
Results date posted
| 2023 | Year | 01 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 01 | Month | 06 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2023 | 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 | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056162
