UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of L-theanine on depressive symptoms
Title of the study (Brief title)	Effect of L-theanine on depressive symptoms
Region	Japan

Condition
Condition	mood disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We evaluate possible effect of L-theanine on depressive symptoms in patients with mood disorder.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II,III

Assessment
Primary outcomes	The severity change of depressive symptoms.
Key secondary outcomes	The change of cognition.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	L-theanine 250mg/day once a day for 2 months.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Subjects were patients with major or minor depressive disorder according to the DSM-IV criteria.
Key exclusion criteria	Participants were excluded if they had a prior medical history of central nervous system disease or severe head injury, or if they met the criteria for substance abuse or dependence. 20
Target sample size	20

Research contact person
Name of lead principal investigator	Hirosi Kunugi
Organization	National Center of Neurology and Psychiatry
Division name	Department of Mental Disorder Research, National Institute of Neuroscience
Address	Department of Mental Disorder Research, National Institute of Neuroscience
TEL	0423412712
Email	hkunugi@ncnp.go.jjp

Public contact
Name of contact person	Miho Ota
Organization	National Center of Neurology and Psychiatry
Division name	Department of Mental Disorder Research, National Institute of Neuroscience
Address	Department of Mental Disorder Research, National Institute of Neuroscience
TEL	0423412712
Homepage URL	http://www.ncnp.go.jp/nin/guide/r3/index.html
Email	ota@ncnp.go.p

Sponsor
Institute	The ethics committee of the National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization	This research was funded by an unrestricted research grant provided by the Taiyo Life Insurance Himawari Foundation, Tokyo, Japan.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Taiyo Kagaku Co., Ltd
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	国立精神・神経医療研究センター（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 09 Month 30 Day
Anticipated trial start date	2014 Year 10 Month 15 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Related information
URL releasing protocol	http://www.ncnp.go.jp/nin/guide/r3/index.html
Publication of results	Published
URL releasing results	http://www.ncnp.go.jp/nin/guide/r3/index.html
Results
Other related information

Management information
Registered date	2014 Year 07 Month 25 Day
Last modified on	2017 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017047