UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048309 |
|---|---|
| Receipt number | R000054616 |
| Scientific Title | Observational study of the effect of aripiprazole on waking difficulty |
| Date of disclosure of the study information | 2022/07/10 |
| Last modified on | 2023/08/30 12:11:23 |
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Basic information
Public title
Observational study of the effect of aripiprazole on waking difficulty
Acronym
Observational study of the effect of aripiprazole on waking difficulty
Scientific Title
Observational study of the effect of aripiprazole on waking difficulty
Scientific Title:Acronym
Observational study of the effect of aripiprazole on waking difficulty
Region
| Japan |
Condition
Condition
Patient being treated for depression with difficulty waking up for which aripiprazole was prescribed
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the response of depressed patients receiving aripiprazole as a treatment to psychiatric symptoms and difficulty waking using objective measures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Aripiprazole is administered for 28 days, and actigraph and PSG are performed before and after administration.
Actigraphic and PSG data will be investigated.
Key secondary outcomes
1,Japanese version of Karolinska. Sleepiness Scale:State of sleepiness
2,Visual Analog Scale: Difficulty falling asleep, awakening in the middle of the day, difficulty sleeping soundly, mood, evaluation of sleepiness
3,Epworth sleepiness Scale: Subfective sleep quality
4,the Japanese version of the Pittsburgh Sleep Quality Index: Subjective sleep quality severity
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 12 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who have been diagnosed with major depressive disorder by DSM-V (Diagnostic and Statistical Manual of Disorders) and being treated with antidepressants.
2. Willingness and ability to follow the procedures of this study, including response to wearing the actigraph and consent to information collection. (In the case of minors, consent will be obtained from parents and guardians.)
Key exclusion criteria
1. Patients witha history of serious psychosomatic disorders.
2. Patients with a history of suicidal ideation or attempts.
3. Patients taking aripiprazole with contraindications or precautions.
4. Pregnant women, patients who may become pregnant, patients who wish to become pregnant, and lactating patients.
5. Patients who are deemed incapable of consenting to research.
6. Patients who are otherwise classified as unfit by the attending physicians for the research.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hayato |
| Middle name | |
| Last name | Ohshima |
Organization
Kurume University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
830-0011
Address
67 Asahi mati, Kurume city, Fukuoka, Japan.
TEL
0942-31-7564
ohshima_hayato@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Hayato |
| Middle name | |
| Last name | Ohshima |
Organization
Kurume University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
830-0011
Address
67 Asahi mati, Kurume city, Fukuoka, Japan.
TEL
0942-31-7564
Homepage URL
ohshima_hayato@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kurume University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical research in Kurume University
Address
67 Asahi mati, Kurume city, Fukuoka, Japan.
Tel
0942-35-3311
i_rinri@kurume-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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 10 | 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
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 04 | Month | 30 | Day |
Other
Other related information
case series studies
Management information
Registered date
| 2022 | Year | 07 | Month | 07 | Day |
Last modified on
| 2023 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054616
