UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007825 |
|---|---|
| Receipt number | R000009222 |
| Scientific Title | Study for biomarkers and molecular pathophysiology of depression diversity |
| Date of disclosure of the study information | 2012/04/24 |
| Last modified on | 2014/04/24 11:57:55 |
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Basic information
Public title
Study for biomarkers and molecular pathophysiology of depression diversity
Acronym
Study for biomarkers and molecular pathophysiology of depression diversity
Scientific Title
Study for biomarkers and molecular pathophysiology of depression diversity
Scientific Title:Acronym
Study for biomarkers and molecular pathophysiology of depression diversity
Region
| Japan |
Condition
Condition
Major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to investigate the differences of vulnerability for stress (i.e., life events) and biological mechanisms among young-onset (onset below 40 aged, middle- or senile-onset (onset above 40 aged) depressive patient and healthy control groups.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Assessments by Near Infra- Red Spectoroscopy, 123I-IMP-SPECT, 3T-Magnetic Resonance Image (MRI), gene and blood sampling to compare among young-onset (onset below 40 aged), middle- or senile-onset (onset above 40 aged) depressive patient and healthy control groups.
Key secondary outcomes
Assessment by prognosis after treatment, and atherosclerotic factors.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Gene | Device,equipment |
Interventions/Control_1
Comparison of genetic differences among young-onset (onset below 40 aged), middle- or senile-onset (onset above 40 aged) depressive and healthy control patient groups.
Interventions/Control_2
Comparison of regional brain blood flow among young-onset (onset below 40 aged), middle- or senile-onset (onset above 40 aged) depressive patient and healthy control groups, using 123I-IMP-SPECT with intravenous injection of N-Isopropyl-4-iodo-a-
methylphenethylamine.
Interventions/Control_3
Comparison of regional brain morphometry and white matter hyper-intensity among young-onset (onset below 40 aged), middle- or senile-onset (onset above 40 aged) depressive patient and healthy control groups, using brain MRI.
Interventions/Control_4
Comparison of time course of brain blood flow for verbal fluency test among young-onset (onset below 40 aged), middle- or senile-onset (onset above 40 aged) depressive patient and healthy control groups, using Near Infra- Red Spectoroscopy.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
This study includes major depressive patients and age- and gender-matched healthy controls, in accordance with following inclusion criteria.
1) Major depressive patients are detected in accordance with Diagnostic and Statistical Manual of Mental Disorder (DSM-IV-TR)
2) Inpatient and out-patient
3) Diagnostic using Mini-International Neuropsychiatric Interview (MINI)
4) Above 50 aged
5) Major Depressive Disorder, Single Episode and multiple episode
6) Major Depressive Disorder with melancholia
7) The patients with above 18 points using Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D)
8) The remission period is detected in accordance with below 8 points by Structured Interview Guide for the Hamilton Depression Rating Scale(SIGH-D)
9) Patents with and without drug administration
Key exclusion criteria
This study excludes major depressive patients and age- and gender-matched healthy controls, in accordance with following exclusion criteria.
1) The subjects with contraindication for MRI, i.e., heart pacer user
2) The subjects with significant physical illness
3) The pregnant or lactating women
4) The Patents during involuntary admission
5) The Patents during emergency admission
6) The patients, whom medical doctor exclude as impropriety
7) The healthy controls, who has a the first-degree relatives with psychiatric disorders
8) The patients with below 23 points of MMSE
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Mikuni |
Organization
Gunma University Graduate School of Medicine
Division name
Psychiatry and Neuroscience
Zip code
Address
Department of Psychiatry and Human Behavior, Gunma University Graduate School of Medicine, 3-39-22 Showa-machi,Maebashi, Gunma 371-8511, Japan
TEL
027-220-8185
mikuni@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosuke Narita |
Organization
Gunma University Graduate School of Medicine
Division name
Psychiatry and Neuroscience
Zip code
Address
Department of Psychiatry and Human Behavior, Gunma University Graduate School of Medicine, 3-39-22 S
TEL
027-220-8185
Homepage URL
knarita@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Division of neuropsychiatry, department of neuroscience, Yamaguchi university graduate school of medicine
Name of secondary funder(s)
MEXT
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
群馬大学医学部付属病院（群馬県）／Gunma university hospital
山口大学医学部付属病院(山口県)／Yamaguchi university hospital
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 24 | 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
| 2012 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 24 | Day |
Last modified on
| 2014 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009222
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