UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001228 |
|---|---|
| Receipt number | R000001492 |
| Scientific Title | Neuroimaging study for late-life depression |
| Date of disclosure of the study information | 2008/07/02 |
| Last modified on | 2010/10/15 18:15:36 |
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Basic information
Public title
Neuroimaging study for late-life depression
Acronym
Neuroimaging for late-life depression
Scientific Title
Neuroimaging study for late-life depression
Scientific Title:Acronym
Neuroimaging for late-life depression
Region
| Japan |
Condition
Condition
late-life depression
Classification by specialty
| Psychiatry | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationships between clinical symptoms and neuropsychological and neuroimaging findings in late-life depression
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Findings of the comparison between depression patients and age- and gender-matched normal controls with regard to the following factors:
PET study (serotonin-transporter binding, amyloid deposition, and glucose metabolism)
Structural MRI
Neuropsychology
Key secondary outcomes
Relationships between clinical symptoms or disease course and neuroimaging or neuropsychological tests
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
PET, MRI, Neuropsychology
Interventions/Control_2
PET, MRI, Neuropsychology
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
| 60 | years-old | <= |
Age-upper limit
| 84 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria for patients
1) Age, 60-84 years
2) Diagnosis, major depressive disorder as defined by the criteria of DSM-IV-TR
3) Subjects who have the ability to provide informed consent
Inclusion criteria for normal controls
1) Age, 60-84 years
2) Mini-mental state examination score, >23 points
3) No current or past history of psychiatric disorders and no current medical conditions
4) Subjects who have the ability to provide informed consent
5) Subjects who are judged by researchers as suitable for participation in the study
Key exclusion criteria
Exclusion criteria for patients
1) Serious suicidal ideation or behavior
2) Mini-mental state examination score at screening, <=23 points
3) Co-morbid other psychiatric disorders including drug dependence
4) Existence of brain organic disease, including current or past history of cerebrovascular disease, Parkinson's disease, and other related disorders
5) Existence of serious medical illnesses
6) Subjects who are judged by researchers as not suitable for participation in the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Harumasa Takano, MD, PhD |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
Address
Anagawa 4-9-1, Inage-ku, Chiba City, Chiba 263-8555, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
| 2008 | Year | 07 | Month | 02 | 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
Date of protocol fixation
| 2008 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | 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
| 2008 | Year | 07 | Month | 02 | Day |
Last modified on
| 2010 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001492
