UMIN-CTR Clinical Trial

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
Email	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
Email	kadotani@belle.shiga-med.ac.jpjp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030725