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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012050
Receipt No. 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 2017/10/20

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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
Email 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
Email khsuzuki@nirs.go.jp

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

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
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
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 No longer recruiting
Date of protocol fixation
2013 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 18 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
2013 Year 10 Month 16 Day
Last modified on
2017 Year 10 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014087

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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