UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011429
Receipt number 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 18:13:47

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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 or person

Institute

National Institute of Radiological Sciences

Institute

Department

Personal name



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

Value
https://center6.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