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

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 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


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

Value
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