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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017484
Receipt No. R000020264
Scientific Title The association among cognitive function, arteriosclerosis and GABA-A receptor in geriatric depressive patients.
Date of disclosure of the study information 2015/05/20
Last modified on 2015/05/10

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Basic information
Public title The association among cognitive function, arteriosclerosis and GABA-A receptor in geriatric depressive patients.
Acronym Geriatric depression
Scientific Title The association among cognitive function, arteriosclerosis and GABA-A receptor in geriatric depressive patients.
Scientific Title:Acronym Geriatric depression
Region
Japan

Condition
Condition Major depressive patitents from 50 to 79 years old and healthy controls
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation about the association among cognitive function, arteriosclerosis and GABA-A receptor using blood sampling, cartoid US, MEG, MRI, and SPECT.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes CANTAB, HOMA-R, voxel based morphometory, GABA-A recepror distribution
Key secondary outcomes Neuronal connectivety

Base
Study type

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Iomazenil spect
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
50 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Age range, 50 - 79 years old.
2) Major depression detected by DSM-IV.
3) HAM-D, below 10 points.
4) Out or In-patents in Gunma university hospital.
5) All the subjects provided their written informed consent.
Key exclusion criteria 1) The subjects can not receive MRIbecause of medical condition, e.g., heart pacer.
2) The subjects have the following illness, i.e., DM, stroke, AMI, angina pectoris, liver dysfunction, renal dysfunction, cancer, epilepsy, or dementia.
3) The subjects have been receiveing the following drug treatments, i.e., hypercholesterolemia, hypertension, steroid, or insomnia.
4) Involuntary admission
5) Hospitalization for Medical Care and Protection
6) unconscousness
7) The patient without notice of diagnosis.
8) The subjects disallowed by medical staff in this research
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Fukuda
Organization Gunma university hospital
Division name Department of Psychiatry and Neuroscience
Zip code
Address 3-39-22 Showa-machi, Maebashi, Gunma 371-8511
TEL 027-220-8180
Email fukuda-psy@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Narita Kosuke
Organization Gunma university hospital
Division name Department of Psychiatry and Neuroscience
Zip code
Address 3-39-22 Showa-machi, Maebashi, Gunma 371-8511
TEL 027-220-8186
Homepage URL
Email knarita@gunma-u.ac.jp

Sponsor
Institute Department of Psychiatry and Neuroscience, Gunma university hospital
Institute
Department

Funding Source
Organization a Grant-in-Aid for Scientific Research (C) (No. 23591695)
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
2015 Year 05 Month 20 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 Open public recruiting
Date of protocol fixation
2015 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 20 Day
Last follow-up date
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 10 Day
Last modified on
2015 Year 05 Month 10 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020264

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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