UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory clinical trial of information therapy using inaudible sounds for depression
Title of the study (Brief title)	Information therapy for depression
Region	Japan

Condition
Condition	major depressive disorder
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of information therapy using inaudible sounds for depression
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change from the baseline by the HAM-D scores after 4-week information therapy
Key secondary outcomes	Change from the baseline by the following items 1. EEG 2. MRI 3. Medication 4. Activities of daily living (ADL) Following items in relation to safety 5. Attrition rate of any cause 6. All adverse events

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	Treatment
Type of intervention	Other
Interventions/Control_1	Exposure of inaudible sounds for 4 weeks
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who meet criteria of major depresive disorder by DSM-5
Key exclusion criteria	1. In case they show suicide attempt, excitement and violence. 2. In case they have history of developmental disorder, bipolar disorder or alchol/drug abuse. 3. In case they have hearing difficulties.
Target sample size	30

Research contact person
Name of lead principal investigator	Manabu Honda
Organization	National Center of Neurology and Psychiatry
Division name	Department of Functional Brain Research, National Institute of Neuroscience
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan
TEL	042-346-1718
Email	honda@ncnp.go.jp

Public contact
Name of contact person	Yuichi Yamashita
Organization	National Center of Neurology and Psychiatry
Division name	Department of Functional Brain Research, National Institute of Neuroscience
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan
TEL	042-346-1718
Homepage URL
Email	yamay@ncnp.go.jp

Sponsor
Institute	National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization	National Center of Neurology and Psychiatry
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

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 04 Month 02 Day
Anticipated trial start date	2014 Year 10 Month 01 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	2014 Year 10 Month 01 Day
Last modified on	2017 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017255