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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007006
Receipt No. R000008266
Scientific Title The effect of L-theanine on psychotic symptoms in human
Date of disclosure of the study information 2012/01/04
Last modified on 2017/01/10

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Basic information
Public title The effect of L-theanine on psychotic symptoms in human
Acronym The effect of L-theanine in human
Scientific Title The effect of L-theanine on psychotic symptoms in human
Scientific Title:Acronym 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
1st name
Middle name
Last name Miho Ota
Organization National Institute of Neuroscience, National Center of Neurology and Psychiatry
Division name Department of Mental Disorder Research
Zip code
Address 4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL 042-341-2712
Email ota@ncnp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miho Ota
Organization National Institute of Neuroscience, National Center of Neurology and Psychiatry
Division name Department of Mental Disorder Research
Zip code
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)

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
2012 Year 01 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

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
2012 Year 01 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000008266

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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