Schizophrenia
Conditions
Interventions
Administration of betaine (3g) twice per day (6g/day) for 8 weeks
Sponsors
Department of Neuropsychiatry, The University of Tokyo Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed as schizophrenia based on DSM-IV-TR 2) Written informed consent after a detailed explanation of this study
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global Assessment of Functioning (GAF) Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive and Negative Syndrome Scale (PANSS) Plasma total homocysteine Plasma homocystine Plasma methionine Serum vitamin B6 Serum vitamin B12 Serum folate DNA | — |
Countries
Japan
Contacts
Public ContactKenji Kirihara
The University of Tokyo Hospital Department of Neuropsychiatry
Outcome results
None listed