UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047036 |
|---|---|
| Receipt number | R000053538 |
| Scientific Title | Relationship between the effects of vortioxetine and sleep EEG findings in depression |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2023/08/31 13:00:59 |
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Basic information
Public title
Relationship between the effects of vortioxetine and sleep EEG findings in depression
Acronym
Relationship between the effects of vortioxetine and sleep EEG findings in depression
Scientific Title
Relationship between the effects of vortioxetine and sleep EEG findings in depression
Scientific Title:Acronym
Relationship between the effects of vortioxetine and sleep EEG findings in depression
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the relationship between the antidepressant effect of vortioxetine and sleep EEG findings.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in sleep EEG during the course of treatment
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Recording sleep EEG
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects between the ages of 20 and 65 years at the time of consent
2) Subjects who provided informed consent by his/her free will with sufficient explanation and understanding for participation in the study
3) Subjects who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for major depressive disorder
4) Subjects who are scheduled to receive vortioxetine
Key exclusion criteria
1) Those who have received antidepressants within the past 4 weeks
2) Patients who have or have had any of the following disorders:
- Schizophrenia or other psychotic disorders
- Bipolar disorder
- Dementia or other neurodegenerative diseases
- Substance abuse including alcohol
3) Patients with severe physical illness
4) Pregnant or lactating women or those who wish to get pregnant during the observation period of the study
5) Others who are judged to be inappropriate by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Suzuki |
Organization
Nihon University Itabashi Hospital
Division name
Psychiatry
Zip code
173-8610
Address
30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo
TEL
03-3972-8111
suzuki.masahiro94@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Suzuki |
Organization
Nihon University Itabashi Hospital
Division name
Psychiatry
Zip code
173-8610
Address
30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
suzuki.masahiro94@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Itabashi Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NIhon University Itabashi Hospital, Clinical Research Judging Committee
Address
30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo
Tel
03-3972-8111
med.rinsyokenkyu@nihon-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 | 03 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | 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 | 02 | Month | 28 | Day |
Last modified on
| 2023 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053538
