UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001228
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001492

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.