UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Depression Based on Measurement of Brain Activity Induced by Emotional Stimuli: A Study using the Depression Detection System
Title of the study (Brief title)	Evaluation of Depression Based on Measurement of Brain Activity Induced by Emotional Stimuli: A Study using the Depression Detection System
Region	Japan

Condition
Condition	Healthy control Major depressive disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to compare the stronger reaction of patients with depression to unpleasant images than to pleasant ones, which is assumed in depressed patients, to the findings from previous MRI studies by measuring the amount of heat generated by brain activity, using the depression detection system.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Determinants of depression. 2. The possibility of change caused by treatment in the amount of heat generated by brain activity. 3. Predictors before treatment for the amount of heat generated by brain activity, responding to treatment.
Key secondary outcomes	1. The relationship to near-infrared spectroscopy (NIRS) signals, whose diagnostic significance has been established.

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	Prevention
Type of intervention	Other
Interventions/Control_1	Individuals with depression
Interventions/Control_2	Healthy control
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. Patients who are diagnosed with major depression according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and are currently depressed (The score should be 7 or higher). 2. Patients between the ages of 20-65. 3. Patients who scored higher than 70 of estimated premorbid IQ in JART(Japanese Adult Reading Test).
Key exclusion criteria	1. Patients who have strong suicidal ideation. 2. Patients who are currently being treated for alcohol/drug abuse. 3. Patients who have serious physical illness. 4.Patients who were determined by their doctors or head researchers to be inappropriate for research subjects for other reasons.
Target sample size	40

Research contact person
Name of lead principal investigator	Koichi Kaneko
Organization	Tottori University Faculty of Medicine
Division name	Division of Neuropsychiatry, Department of Brain and Neuroscience
Address	36-1 Nishi-cho, Yonago, Tottori
TEL	0859-38-6547
Email	kaneko@med.tottori-u.ac.jp

Public contact
Name of contact person	Shenghong Pu
Organization	Tottori University Faculty of Medicine
Division name	Division of Neuropsychiatry, Department of Brain and Neuroscience
Address	36-1 Nishi-cho, Yonago, Tottori
TEL	0859-38-6547
Homepage URL
Email	pshh0517@yahoo.co.jp

Sponsor
Institute	Tottori University Faculty of Medicine
Institute
Department

Funding Source
Organization	Tottori University Faculty of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	鳥取大学医学部附属病院（鳥取県米子市）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 15 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 08 Month 12 Day
Anticipated trial start date	2016 Year 08 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 12 Day
Last modified on	2016 Year 08 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027172