UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024046 |
|---|---|
| Receipt number | 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 19:51:20 |
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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
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
jimu_dpsy@irides-dpsy.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate school of Medicine
Department of Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027691
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
