Efficacy and safety of Yokukansan for the treatment-resistant schizophrenia: randomized, double-blind, placebo-controlled multicenter trial

Efficacy and safety of Yokukansan for the treatment-resistant schizophrenia: randomized, double-blind, placebo-controlled multicenter trial - Efficacy of Yokukansan for the treatment-resistant schizophrenia: randomized, double-blind, placebo-controlled multicenter trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005018

Enrollment

120

Registered

2011-02-03

Start date

2011-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment-Rsistant Schizophrenia

Interventions

Yokukansan peroral administration 5-7.5g/day Plasebo peroral administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects were patients meeting DSM-IV-TR, criteria for schizophrenia, who were free of other psychiatric diagnoses or concurrent medical illness and met treatment-resistance criteria.

Exclusion criteria

Exclusion criteria: Personality disorder etc

Design outcomes

Primary

Measure	Time frame
Positive and Negative Syndrome Scale (PANSS)	—

Secondary

Measure	Time frame
Clinical Global Impression (CGI) Global Assessment of Function (GAF) Drug-induced Extrapyramidal Symptom Scale (DIEPSS)	—

Countries

Japan

Contacts

Public ContactTsuyoshi Miyaoka

Shimane University School of Medicine Psychiatry

miyanyan@med.shimane-u.ac.jp0853-20-2262

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026