An exploratory trial of betaine supplementation in patients with schizophrenia

Phase 2

• Conditions: Schizophrenia

• Registration Number: JPRN-UMIN000017295
• Lead Sponsor: Department of Neuropsychiatry, The University of Tokyo Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-01
• Study Completion: 2020-06-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

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) Adverse events

Secondary Outcome Measures

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