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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011429
Receipt No. R000013381
Scientific Title A study to develop blood biomarkers to diagnose patients in depressive state
Date of disclosure of the study information 2013/08/08
Last modified on 2013/08/08

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Basic information
Public title A study to develop blood biomarkers to diagnose patients in depressive state
Acronym A study to develop blood biomarkers to diagnose patients in depressive state
Scientific Title A study to develop blood biomarkers to diagnose patients in depressive state
Scientific Title:Acronym A study to develop blood biomarkers to diagnose patients in depressive state
Region
Japan

Condition
Condition - Patients with depression
- Healthy volunteer
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To measure blood biomarkers that can diagnose patients with depression, and to examine relationship among the biomarkers, symptom and imaging data including positron emission tomography (PET) and magnetic resonance imaging (MRI).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Prevalence of polymorphism of monoamine-related molecule in patients with depression and healthy volunteers corresponding to change in PET/MRI data and symptom.
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
60 years-old >=
Gender Male and Female
Key inclusion criteria Healthy subjects:
Do not have any psychiatric disorders currently, nor have had similar disorders in the past
Able to understand an explanatory document and give consent
Patients:
Patients in depressive state. Able to understand an explanatory document and give consent
Key exclusion criteria Healthy subjects:
Pregnant or possible to become pregnant Currently breastfeeding
Have a cardiac pacemaker or other metals in the body, such as brain clip or bolt Participating in other studies involving the use of nuclear medicine within the past 6 months, in terms of radiation safety
Other: judged inappropriate as a subject by the investigator
Patients:
Severe suicidal tendency
Presence of other comorbid psychiatric disorders
Have taken antidepressants and/or antipsychotic drugs within 1 month prior to the first examination
Have organic brain diseases
Have current severe physical diseases Pregnant or possible to become pregnant Currently breastfeeding
Have a cardiac pacemaker or other metals in the body, such as brain clip or bolt
Other: judged inappropriate as a subject by the investigator
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Suhara
Organization National Institute of Radiological Sciences
Division name Molecular Imaging Center
Zip code
Address 4-9-1 Anagawa, Inage-ku, Chiba
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization National Institute of Radiological Sciences
Division name A study ethic plan support room
Zip code
Address
TEL
Homepage URL
Email helsinki@nirs.go.jp

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 08 Month 08 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 Enrolling by invitation
Date of protocol fixation
2013 Year 01 Month 21 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Measuring blood biomarkers

Management information
Registered date
2013 Year 08 Month 08 Day
Last modified on
2013 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013381

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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