UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of L-theanine on psychotic symptoms in human
Title of the study (Brief title)	The effect of L-theanine in human
Region	Japan

Condition
Condition	schizophrenia
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	L-theanine is an amino acid historically considered to have an influence on cognition et al. However, its psychotropic effects remain unclear. In this study, we evaluate the effect of L-theanine in schizophrenic patients and healthy subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We evaluate the effect og theanine on the severity of schizophrenic symptoms and cognitive functions.
Key secondary outcomes

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	Food
Interventions/Control_1	8 weeks 250mg per a day once a day
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	Schizophrenics diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, and age and sex matched healthy subjects were recruited. Written informed consent was obtained for the participation in the study from all subjects.
Key exclusion criteria	Participants were excluded if they had a prior medical history of central nervous system disease or severe head injury.
Target sample size	30

Research contact person
Name of lead principal investigator	Miho Ota
Organization	National Institute of Neuroscience, National Center of Neurology and Psychiatry
Division name	Department of Mental Disorder Research
Address	4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL	042-341-2712
Email	ota@ncnp.go.jp

Public contact
Name of contact person	Miho Ota
Organization	National Institute of Neuroscience, National Center of Neurology and Psychiatry
Division name	Department of Mental Disorder Research
Address	4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL	042-341-2712
Homepage URL
Email	ota@ncnp.go.jp

Sponsor
Institute	National Institute of Neuroscience, National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization	Taiyo Life Insurance Himawari Foundation
Organization
Division
Category of Funding Organization	Profit organization
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	2012 Year 01 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 01 Month 01 Day
Anticipated trial start date	2012 Year 01 Month 04 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 01 Month 04 Day
Last modified on	2017 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008266