UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017295 |
|---|---|
| Receipt number | 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 | 2024/05/26 16:43:19 |
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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
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
kirihara-tky@umin.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, The University of Tokyo Hospital
Institute
Department
Personal name
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
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
https://jrct.niph.go.jp/latest-detail/jRCTs031180371
Publication of results
Published
Result
URL related to results and publications
https://jrct.niph.go.jp/latest-detail/jRCTs031180371
Number of participants that the trial has enrolled
15
Results
As a primary endpoint, GAF score improved significantly after betaine supplementation in neither FAS (Full Analysis Set) nor PPS (Per Protocol Set).
As a secondary endpoint, PANSS positive symptoms score improved significantly after betaine supplementation in PPS but not FAS.
As a secondary endpoint, plasma methionine increased significantly after betaine supplementation in PPS.
Results date posted
| 2024 | Year | 05 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Full Analysis Set (FAS)
15 patients with schizophrenia: male 11/ female 4, 35.1+-8.2 years
Per Protocol Set (PPS)
10 patients with schizophrenia: male 6/ female 4, 36.7+-9.2 years
Participant flow
15 participants were enrolled. 10 participants completed and 5 participants dropped out.
Adverse events
1 participant showed worsening of psychosis and stopped betaine supplementation.
11 participants showed increased plasma levels of methionine, but all of them recovered without any treatments.
Outcome measures
Positive and Negative Syndrome Scale (PANSS)
Plasma total homocysteine
Plasma homocystine
Plasma methionine
Serum vitamin B6
Serum vitamin B12
Serum folate
DNA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2024 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020065
