UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024046
Receipt No. R000027691
Scientific Title Development of personalized medicine for depressed patients by elucidating the pathogeneses of depression considering involvement of nutrition, lifestyle and inflammation
Date of disclosure of the study information 2016/09/14
Last modified on 2019/03/20

* 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 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
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
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/ctr_e/ctr_view.cgi?recptno=R000027691

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.