Unique ID issued by UMIN | UMIN000015709 |
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Receipt number | R000018264 |
Scientific Title | Efficacy and Safety of Yokukansan in Schizophrenia: A Randomized, Multi-center, Double-Blind, Placebo-Controlled Trial |
Date of disclosure of the study information | 2014/11/25 |
Last modified on | 2014/11/17 18:36:30 |
Efficacy and Safety of Yokukansan in Schizophrenia:
A Randomized, Multi-center, Double-Blind, Placebo-Controlled Trial
Yokukansan for Schizophrenia
Efficacy and Safety of Yokukansan in Schizophrenia:
A Randomized, Multi-center, Double-Blind, Placebo-Controlled Trial
Yokukansan for Schizophrenia
Japan |
Schizophrenia
Psychiatry |
Others
NO
This study aimed to evaluate the efficacy and tolerability of TJ-54 as an add-on pharmacotherapy for clinical symptoms in patients with schizophrenia over a 12-week period.
Safety,Efficacy
Positive and Negative Syndrome Scale
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
Yokukansan
Placebo
18 | years-old | <= |
70 | years-old | >= |
Male and Female
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 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.
60
1st name | |
Middle name | |
Last name | Tsuyoshi Miyaoka |
Shimane University School of Medicine
Psychiatry
Enyacho 89-1, Izumo
0853-20-2262
miyanyan@med.shimane-u.ac.jp
1st name | |
Middle name | |
Last name | Sakura Hino |
Shimane University School of Medicine
Psychiatry
Enyacho 89-1, Izumo
0853-20-2262
saku4444@med.shimane-u.ac.jp
Shimane University School of Medicine
The Waksman Foundation of Japan INC
Non profit foundation
Japan
NO
Shimane University School of Medicine
2014 | Year | 11 | Month | 25 | Day |
Unpublished
Open public recruiting
2014 | Year | 09 | Month | 17 | Day |
2014 | Year | 10 | Month | 25 | Day |
2014 | Year | 11 | Month | 17 | Day |
2014 | Year | 11 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018264
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