UMIN-CTR Clinical Trial

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