Schizophrenia
Conditions
Interventions
Yokukansan
Placebo
Sponsors
Shimane University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female hospitalized patients were eligible for inclusion in the study if they met all of the following criteria: a primary Diagnostic and Statistical Manual of Mental Disorders, 4th edn, text revision diagnosis of schizophrenia, established by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, with a length of at least 3 years; history of documented treatment-resistant status, which is defined as the absence of clinically significant improvement after treatment with at least 2 neuroleptics for 6 weeks or longer after receiving a full dose equivalent to 600 mg/day of chlorpromazine; presence of persistent positive symptoms as evident by a score of at least 10 on the positive symptom subscale of the Positive and Negative Syndrome Scale; and an overall score of at least 60 on the PANSS on the Clinical Global Impression-Severity.
Exclusion criteria
Exclusion criteria: Exclusion criteria included pregnancy, lactation, other clinical significant or unstable conditions, and history of alcohol or substance abuse in the last 6 months. No patients had been treated by clozapine in this clinical trial. Because the clozapine has not been available in Japan until 2009, therefore it might have been difficult to include patients who had gone clozapine trial in the past.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive and Negative Syndrome Scale | — |
Countries
Japan
Contacts
Public ContactSakura Hino
Shimane University School of Medicine Psychiatry
Outcome results
None listed