UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026835
Receipt No. 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 2019/03/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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 No longer recruiting
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 12 Month 31 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
2019 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030725

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.