A clinical trial of betaine in schizophrenia

JRCT ID: jRCTs031180371

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Schizophrenia
• Date of first enrollment: 06/12/2016
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Administration of betaine (3g) twice per day (6g/day) for 8 weeks

Outcome(s)

Primary Outcome

Global Assessment of Functioning (GAF)
Adverse events

Secondary Outcome

Positive and Negative Syndrome Scale (PANSS)
Plasma total homocysteine
Plasma homocystine
Plasma methionine
Serum vitamin B6
Serum vitamin B12
Serum folate
DNA

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 64age old
• Gender: Both

Include criteria

1) Diagnosed as schizophrenia based on DSM-IV-TR
2) Written informed consent after a detailed explanation of this study

Exclude 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

Related Information

• Primary Sponsor: Kasai Kiyoto
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Takeda Science Foundation,Ministry of Education, Culture, Sports, Science and Technology,The Mitsubishi Foundation
• Secondary ID(s): UMIN000017295