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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017295
Receipt No. R000020065
Scientific Title An exploratory trial of betaine supplementation in patients with schizophrenia
Date of disclosure of the study information 2015/06/01
Last modified on 2020/10/29

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Basic information
Public title An exploratory trial of betaine supplementation in patients with schizophrenia
Acronym An exploratory trial of betaine supplementation in patients with schizophrenia
Scientific Title An exploratory trial of betaine supplementation in patients with schizophrenia
Scientific Title:Acronym An exploratory trial of betaine supplementation in patients with schizophrenia
Region
Japan

Condition
Condition Schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To investigate safety and efficacy of betaine supplementation on clinical symptoms and functioning in patients with schizophrenia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Global Assessment of Functioning (GAF)
Adverse events
Key secondary outcomes Positive and Negative Syndrome Scale (PANSS)
Plasma total homocysteine
Plasma homocystine
Plasma methionine
Serum vitamin B6
Serum vitamin B12
Serum folate
DNA

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
Medicine
Interventions/Control_1 Administration of betaine (3g) twice per day (6g/day) for 8 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
64 years-old >=
Gender Male and Female
Key inclusion criteria 1) Diagnosed as schizophrenia based on DSM-IV-TR
2) Written informed consent after a detailed explanation of this study
Key exclusion criteria 1) History of allergy to drugs
2) History of substance use disorder
3) High risk of suicide or other-injuring behavior
4) No agreement with contraception during participation of this study
5) Comorbidity or history of serious physical diseases
6) Organic brain disorder requiring treatment
7) Infection with HIV or hepatitis virus
8) Serious abnormality of vital sign, laboratory data, or electrocardiogram
9) Involuntarily hospital admission
10) Restriction of behavior
11) No disease notification
12) Electroconvulsive therapy or transcranial magnetic stimulation within 3 months before participation of this study
13) History of betaine use
14) Use of investigational drug within 3 months before participation of this study
15) More than 500 micromol/L of plasma methionine level
16) Doctor's decision
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kiyoto
Middle name
Last name Kasai
Organization The University of Tokyo Hospital
Division name Department of Neuropsychiatry
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Email kasaik-tky@umin.ac.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Kirihara
Organization The University of Tokyo Hospital
Division name Department of Neuropsychiatry
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Homepage URL
Email kirihara-tky@umin.ac.jp

Sponsor
Institute Department of Neuropsychiatry, The University of Tokyo Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The University of Tokyo, Clinical Research Review Board
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel 03-5841-0818
Email ethics@m.u-tokyo.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 jRCTs031180371
Org. issuing International ID_1 Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 15
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 No longer recruiting
Date of protocol fixation
2015 Year 02 Month 19 Day
Date of IRB
2015 Year 01 Month 29 Day
Anticipated trial start date
2016 Year 12 Month 06 Day
Last follow-up date
2020 Year 06 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 27 Day
Last modified on
2020 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020065

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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