臨床研究等提出・公開システム

Date of registration	Mar. 18, 2019
Last modified on	April. 01, 2022
Trial ID	jRCTs031180371

Scientific Title	An exploratory trial of betaine supplementation in patients with schizophrenia (An exploratory trial of betaine supplementation in patients with schizophrenia)
Public Title	A clinical trial of betaine in schizophrenia (A clinical trial of betaine in schizophrenia)

Completion date	June. 23, 2020
Result actual enrolment	15
Baseline Characteristics	Full Analysis Set (FAS) 15 patients with schizophrenia: male 11/ female 4, 35.1+-8.2 years Per Protocol Set (PPS) 10 patients with schizophrenia: male 6/ female 4, 36.7+-9.2 years
Participant flow	15 participants were enrolled. 10 participants completed and 5 participants dropped out.
Adverse events	1 participant showed worsening of psychosis and stopped betaine supplementation. 11 participants showed increased plasma levels of methionine, but all of them recovered without any treatments.
Outcome measures	As a primary endpoint, GAF score improved significantly after betaine supplementation in neither FAS nor PPS. As a secondary endpoint, PANSS positive symptoms score improved significantly after betaine supplementation in PPS but not FAS. As a secondary endpoint, plasma methionine increased significantly after betaine supplementation in PPS. Plasma betaine increased significantly after betaine supplementation. Increased plasma betaine significantly correlated with improvement of positive symptoms.
Brief summary	The findings of the current study suggest that betaine supplementation may improve positive symptoms in patients with schizophrenia.
Date of posting of results summaries	April. 01, 2024

Plan to share IPD	No
Plan description	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs031180371

Contact for Scientific Queries	Name	Kasai Kiyoto
	Affiliation	The University of Tokyo Hospital
	Address	7-3-1 Hongo Bunkyo-ku Tokyo,Japan
	Telephone	+81-3-3815-5411
	E-mail	kasaik-tky@umin.ac.jp
Contact for Public Queries	Name	Kirihara Kenji
	Affiliation	The University of Tokyo Hospital
	Address	7-3-1 Hongo Bunkyo-ku Tokyo,Japan
	Telephone	+81-3-3815-5411
	E-mail	kirihara-tky@umin.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Dec. 06, 2016
Actual date of first enrollment		Dec. 06, 2016
Target sample size		30
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion 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	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
	Age Minimum	20age old over
	Age Maximum	64age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Schizophrenia
Intervention(s)		Administration of betaine (3g) twice per day (6g/day) for 8 weeks
Primary Outcome(s)		Global Assessment of Functioning (GAF) Adverse events
Secondary Outcome(s)		Positive and Negative Syndrome Scale (PANSS) Plasma total homocysteine Plasma homocystine Plasma methionine Serum vitamin B6 Serum vitamin B12 Serum folate DNA

Source of Monetary Support	Japan Agency for Medical Research and Development
Secondary Sponsor	Not applicable

Source of Monetary Support	Takeda Science Foundation
Secondary Sponsor	Not applicable

Source of Monetary Support	Ministry of Education, Culture, Sports, Science and Technology
Secondary Sponsor	Not applicable

Source of Monetary Support	The Mitsubishi Foundation
Secondary Sponsor	Not applicable

Name of Certified Review Board	The University of Tokyo, Clinical Research Review Board
Address	7-3-1, Hongo,Bunkyo-ku, Tokyo
Telephone	+81-3-5841-0818
E-Mail	ethics@m.u-tokyo.ac.jp
Approval Status	Approval
Date of approval	Mar. 04, 2019

Secondary ID(s)	UMIN000017295
Issuing Authority	UMIN-CTR

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
7	April. 01, 2024	(this page)	Changes
6	Mar. 05, 2021	Detail	Changes
5	July. 13, 2020	Detail	Changes
4	April. 13, 2020	Detail	Changes
3	July. 25, 2019	Detail	Changes
2	April. 01, 2019	Detail	Changes
1	Mar. 18, 2019	Detail

List of change history