UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017484 |
|---|---|
| Receipt number | 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 17:35:34 |
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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
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
knarita@gunma-u.ac.jp
Sponsor or person
Institute
Department of Psychiatry and Neuroscience, Gunma university hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020264
