UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009404 |
|---|---|
| Receipt number | R000010286 |
| Scientific Title | Neuroimaging study of dopaminergic neurotransmission in depresive state |
| Date of disclosure of the study information | 2012/11/30 |
| Last modified on | 2012/11/27 15:00:08 |
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Basic information
Public title
Neuroimaging study of dopaminergic neurotransmission in depresive state
Acronym
Neuroimaging study of dopaminergic neurotransmission in depresive state
Scientific Title
Neuroimaging study of dopaminergic neurotransmission in depresive state
Scientific Title:Acronym
Neuroimaging study of dopaminergic neurotransmission in depresive state
Region
| Japan |
Condition
Condition
mood disorder and adjustment disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to clarify the neural basis of depressive state using dopamine PET imaging by assessing regional D1 and D2 receptor binding potentials with [11C]SCH23390 and [11C]raclopride. The effect of therapeutic intervention its association with dopaminergic neurotransmission is also assessed in longitudinal follw-up design.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The association of Dopamine D1 and D2 receptor binding potentials with clinical features
Key secondary outcomes
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
3
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
PET, MRI
Interventions/Control_2
PET, MRI
Interventions/Control_3
PET, MRI
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria for patients
1) Age, 20-60 years
2) Diagnosis, major depressive disorder and adjustment 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, 20-60 years
2) No current or past history of psychiatric disorders and no current medical conditions
3) Subjects who have the ability to provide informed consent
4) 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) Co-morbid other psychiatric disorders including drug dependence
3) Subjects taking antidepressants or antipsychotic agents within 28 days before the examination
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 | Tetsuya Suhara MD, PhD |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
Address
Anagawa 4-9-1, Inage-ku, 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 Education
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
| 2012 | Year | 11 | Month | 30 | 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 | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 27 | Day |
Last modified on
| 2012 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010286
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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