UMIN-CTR Clinical Trial

Basic information
Public title	Development of personalized medicine for depressed patients by elucidating the pathogeneses of depression considering involvement of nutrition, lifestyle and inflammation
Acronym	Development of personalized medicine for depression
Scientific Title	Development of personalized medicine for depressed patients by elucidating the pathogeneses of depression considering involvement of nutrition, lifestyle and inflammation
Scientific Title:Acronym	Development of personalized medicine for depression
Region	Japan

Condition
Condition	Depression, Postpartum depression
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Objectives are: 1) to reveal the pathogeneses for depression by analyzing information and specimens collected by Tohoku Medical Megabank Project (including the population-based adult cohort study, and the birth and three-generation cohort study), considering profiles of subjects regarding nutrition, lifestyle and inflammation, 2) to reveal the pathogeneses of postpartum depression by conducting add-on follow-up studies of the mothers enrolled to the three-generation cohort study, 3) to develop technologies for objective evaluation of depression, and for predictions of onset and prognosis of depression, based on the above findings.
Basic objectives2	Others
Basic objectives -Others	To clarify the pathogeneses of depression and postpartum depression
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[Postpartum depression assessments] Edinburgh Postnatal Depression Scale: EPDS [Assessment of diagnosis and mental state] Semi-structured interview for evaluating mental state [Plasma] 1. Concentrations of protein, lipid, metabolite, etc. 2. Concentrations of inflammatory substances (cytokine, chemokine, complement components, High-sensitive C-reactive protein etc.) 3. Concentrations of hormones (Estradiol, progesterone, testosterone, cortisol, etc.) [Fecal specimens] Intestinal flora (bifidobacteria, lactic acid bacteria, etc.) [Daily life] 1. Physical activities and movement in daily life 2. Daylight hours 3. Sleeping pattern 4. Heart rate
Key secondary outcomes

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	The subjects consists of: 1. Women who have enrolled to the third generation cohort of Tohoku Medical Megabank Organization (approved by the Ethics Committee of Tohoku University Graduate School of Medicine: 2016-4-013, 2014-4-015), and who experienced delivery before April of 2016, and who have become pregnant between April, 2017 and April, 2021. 2. Women who experienced postpartum depression after the previous delivery are prioritized. 3. People who are 20 years of age or more. 4. People who provide written informed consent.
Key exclusion criteria	1. Patients affected by infectious diseases, malignant tumor, severe diabetes, or other severe systemic diseases. 2. Patients who are considered to be inappropriate to participate to this study, by a physician who is in charge of this project or who is involved in the project.
Target sample size	720

Research contact person
Last name of lead principal investigator	1st name Hiroaki Middle name Last name Tomita
Organization	Tohoku University Graduate school of Medicine
Division name	Department of Psychiatry
Zip code	980-8575
Address	2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8573, Japan
TEL	81-22-717-7262
Email	htomita@med.tohoku.ac.jp

Public contact
1st name of contact person	1st name Hiroaki Middle name Last name Tomita
Organization	Tohoku University Graduate school of Medicine
Division name	Department of Psychiatry
Zip code	980-8575
Address	2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8573, Japan
TEL	81-22-717-7897
Homepage URL
Email	jimu_dpsy@irides-dpsy.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate school of Medicine Department of Psychiatry
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	nstitutional Review Board, Graduate school of Medicine, Tohoku University
Address	2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8573, Japan
Tel	81-22-717-8007
Email	med-kenkyo@grp.tohoku.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	2016 Year 09 Month 14 Day

Related information
URL releasing protocol	http://www.mentalhealth.megabank.tohoku.ac.jp/index.html
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	Open public recruiting
Date of protocol fixation	2016 Year 04 Month 01 Day
Date of IRB	2016 Year 09 Month 28 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2016 Year 09 Month 14 Day
Last modified on	2019 Year 03 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027691