A clinical trial of betaine in schizophrenia

Phase 2

• Conditions: Schizophrenia

• Registration Number: JPRN-jRCTs031180371
• Lead Sponsor: Kasai Kiyoto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global Assessment of Functioning (GAF) <br>Adverse events

Secondary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale (PANSS) <br>Plasma total homocysteine <br>Plasma homocystine <br>Plasma methionine <br>Serum vitamin B6 <br>Serum vitamin B12 <br>Serum folate <br>DNA