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 | 2020/10/29 12:32:53 |
An exploratory trial of betaine supplementation in patients with schizophrenia
An exploratory trial of betaine supplementation in patients with schizophrenia
An exploratory trial of betaine supplementation in patients with schizophrenia
An exploratory trial of betaine supplementation in patients with schizophrenia
Japan |
Schizophrenia
Psychiatry |
Others
YES
To investigate safety and efficacy of betaine supplementation on clinical symptoms and functioning in patients with schizophrenia
Safety,Efficacy
Exploratory
Explanatory
Phase II
Global Assessment of Functioning (GAF)
Adverse events
Positive and Negative Syndrome Scale (PANSS)
Plasma total homocysteine
Plasma homocystine
Plasma methionine
Serum vitamin B6
Serum vitamin B12
Serum folate
DNA
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Administration of betaine (3g) twice per day (6g/day) for 8 weeks
20 | years-old | <= |
64 | years-old | >= |
Male and Female
1) Diagnosed as schizophrenia based on DSM-IV-TR
2) Written informed consent after a detailed explanation of this study
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
30
1st name | Kiyoto |
Middle name | |
Last name | Kasai |
The University of Tokyo Hospital
Department of Neuropsychiatry
113-8655
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
03-3815-5411
kasaik-tky@umin.ac.jp
1st name | Kenji |
Middle name | |
Last name | Kirihara |
The University of Tokyo Hospital
Department of Neuropsychiatry
113-8655
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
03-3815-5411
kirihara-tky@umin.ac.jp
Department of Neuropsychiatry, The University of Tokyo Hospital
Japan Agency for Medical Research and Development
Japanese Governmental office
The University of Tokyo, Clinical Research Review Board
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
03-5841-0818
ethics@m.u-tokyo.ac.jp
YES
jRCTs031180371
Japan Registry of Clinical Trials
東京大学医学部附属病院(東京都)
2015 | Year | 06 | Month | 01 | Day |
Unpublished
15
No longer recruiting
2015 | Year | 02 | Month | 19 | Day |
2015 | Year | 01 | Month | 29 | Day |
2016 | Year | 12 | Month | 06 | Day |
2020 | Year | 06 | Month | 23 | Day |
2015 | Year | 04 | Month | 27 | Day |
2020 | Year | 10 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020065
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