UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026835 |
|---|---|
| Receipt number | R000030725 |
| Scientific Title | Practical use of sleep EEG for objective assessment and diagnosis of major depression - Multicenter exploratory prospective study - |
| Date of disclosure of the study information | 2017/04/03 |
| Last modified on | 2021/07/20 17:17:11 |
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Basic information
Public title
Practical use of sleep EEG for objective assessment and diagnosis of major depression - Multicenter exploratory prospective study -
Acronym
SEEDs Study 2
Scientific Title
Practical use of sleep EEG for objective assessment and diagnosis of major depression - Multicenter exploratory prospective study -
Scientific Title:Acronym
SEEDs Study 2
Region
| Japan |
Condition
Condition
Major Depressive Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish a prediction method for the diagnosis of major depressive disorder by using sleep EEG measures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The sleep EEG indices calculated by a basic rhythm analysis program
2. Total sleep time (TST), sleep latency (SL) sleep efficiency (SE), wake after sleep onset (WASO), stage 1 sleep, stage 2 sleep, slow wave sleep (SWS), REM sleep, REM latency, REM density, and time in bed (TIB) etc.
Key secondary outcomes
PHQ-9, BDI, HAM-D, AIS, STAI, PANSS, YMRS, MMSE, PSQI
Demographic characteristics of participants, concurrent medications, clinical observations (Conventional and DSM-5 diagnoses)
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
| 18 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who had insomnia and/or depressive episodes visited research institutes.
2) Participants comprehend the study description, and consent to the study participation by their own free will. As for the participant is a person under age, we need the consent in writing by a legally acceptable representative for their study participation.
Key exclusion criteria
1) Organic brain disorders identified in the brain structural imaging including CT and MRI (taken within past 6 months).
2) Epileptic disorders.
3) Somatic disorders that may cause depressive symptoms such as hypothyroidism, Cushing disease, or SLE.
4) Neurotic disorders that may cause depressive symptoms such as Parkinson disease, Huntington disease, or multiple sclerosis.
5) Sleep apnea syndrome.
6) Disorderly sleep-wake pattern such as graveyard shift or shift-workers.
7) Pathological suicidal ideations and/or suicide attempts.
8) Past episodes of substance use disorder.
9) Addiction to illegal drugs (amphetamine, morphine, cocaine, cannabis, phencyclidine) by Triage test.
10) Prescribed central nervous stimulating drugs, opioid medications (Ritalin, Concerta, and opioids), Modafinil, steroids, and/or interferon.
11) Taking part in and will be going to take part in the other clinical trials during the study period.
12) Ruled unfit to the study participation by the principal investigator or a member of the research project.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kadotani |
Organization
Shiga University of Medical Science
Division name
Department of Sleep and Behavioral Sciences
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
077-548-3632
kadotani@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kadotani |
Organization
Shiga University of Medical Science
Division name
Department of Sleep and Behavioral Sciences
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
077-548-3632
Homepage URL
kadotani@belle.shiga-med.ac.jpjp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Psychiatry, Nihon University
Kobe University
Sleepwell Co.,Ltd.
Name of secondary funder(s)
Sleepwell Co.,Ltd.
IRB Contact (For public release)
Organization
Shiga University of Medical Science Research Ethics Committee
Address
Seta Tsukinowa-cho, Otsu, Shiga
Tel
077-548-3576
hqrec@belle.shiga-med.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
| 2017 | Year | 04 | Month | 03 | Day |
Related information
URL releasing protocol
https://amedfind.amed.go.jp/amed/search/task_search_details.html
Publication of results
Unpublished
Result
URL related to results and publications
https://amedfind.amed.go.jp/amed/search/task_search_details.html
Number of participants that the trial has enrolled
183
Results
183 cases registered.
There were 176 cases analyzed.
Results date posted
| 2021 | Year | 07 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
183 cases registered
Participant flow
7 cases excluded.
There were 176 cases analyzed.
Adverse events
No serious adverse events
Outcome measures
The sleep EEG indices calculated by a basic rhythm analysis program
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 02 | Month | 19 | Day |
Date analysis concluded
| 2021 | Year | 04 | Month | 08 | Day |
Other
Other related information
To establish a prediction method for the diagnosis of major depressive disorder by using sleep EEG measures.
Management information
Registered date
| 2017 | Year | 04 | Month | 03 | Day |
Last modified on
| 2021 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030725
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
