UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012050 |
|---|---|
| Receipt number | R000014087 |
| Scientific Title | Imaging serotonin transmission in the brain of depressed patients. |
| Date of disclosure of the study information | 2013/10/18 |
| Last modified on | 2021/04/29 11:19:19 |
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Basic information
Public title
Imaging serotonin transmission in the brain of depressed patients.
Acronym
Imaging serotonin transmission in the brain of depressed patients.
Scientific Title
Imaging serotonin transmission in the brain of depressed patients.
Scientific Title:Acronym
Imaging serotonin transmission in the brain of depressed patients.
Region
| Japan |
Condition
Condition
Major depressive disorder, Adjustment disorder with depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess serotonin neurotransmission in the patients with depression.
Basic objectives2
Others
Basic objectives -Others
pathophysiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Regional endogenous serotonin release
Key secondary outcomes
Relationship between regional endogenous serotonin release and density of 5-HT1A receptors, blood analysis, symptom, cognitive function and fMRI.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
PET
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Age, 20-65 years
2) Normal healthy volunteers or patients with major depressive disorder and adjustment disorder as defined by the criteria of DSM-IV-TR
Key exclusion criteria
1) Subjects who lack the ability to provide informed consent
2) Subjects who take antidepressants except escitalopram, antipsychotics, mood stabilizers, or tandospirone. Subjects who took those medicines in 1 month.
3) Serious suicidal ideation or behavior
4) Co-morbid other psychiatric disorders including drug dependence
5) Existence of brain organic disease, including current or past history of cerebrovascular disease, Parkinson's disease, and other related disorders
6) Existence of serious medical illnesses
7) Pregnant women
8) lactating woman
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Kubota |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
Department of Functional Brain Imaging Research
Zip code
Address
Anagawa 4-9-1, Inage-ku, Chiba, 263-8555, Japan
TEL
043-206-3251
kubota.manabu@qst.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuko Suzuki |
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
043-206-3251
Homepage URL
khsuzuki@nirs.go.jp
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
Japanese Governmental office
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
| 2013 | Year | 10 | Month | 18 | 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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 16 | Day |
Last modified on
| 2021 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014087
