UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015709 |
|---|---|
| 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 |
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Basic information
Public title
Efficacy and Safety of Yokukansan in Schizophrenia:
A Randomized, Multi-center, Double-Blind, Placebo-Controlled Trial
Acronym
Yokukansan for Schizophrenia
Scientific Title
Efficacy and Safety of Yokukansan in Schizophrenia:
A Randomized, Multi-center, Double-Blind, Placebo-Controlled Trial
Scientific Title:Acronym
Yokukansan for Schizophrenia
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive and Negative Syndrome Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Yokukansan
Interventions/Control_2
Placebo
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Miyaoka |
Organization
Shimane University School of Medicine
Division name
Psychiatry
Zip code
Address
Enyacho 89-1, Izumo
TEL
0853-20-2262
miyanyan@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakura Hino |
Organization
Shimane University School of Medicine
Division name
Psychiatry
Zip code
Address
Enyacho 89-1, Izumo
TEL
0853-20-2262
Homepage URL
saku4444@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Waksman Foundation of Japan INC
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Shimane University School of Medicine
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2014 | Year | 09 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 17 | Day |
Last modified on
| 2014 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018264
