UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005018 |
|---|---|
| Receipt number | R000005912 |
| Scientific Title | Efficacy and safety of Yokukansan for the treatment-resistant schizophrenia: randomized, double-blind, placebo-controlled multicenter trial |
| Date of disclosure of the study information | 2011/02/03 |
| Last modified on | 2012/03/02 11:25:13 |
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Basic information
Public title
Efficacy and safety of Yokukansan for the treatment-resistant schizophrenia:
randomized, double-blind, placebo-controlled multicenter trial
Acronym
Efficacy of Yokukansan for the treatment-resistant schizophrenia:
randomized, double-blind, placebo-controlled multicenter trial
Scientific Title
Efficacy and safety of Yokukansan for the treatment-resistant schizophrenia:
randomized, double-blind, placebo-controlled multicenter trial
Scientific Title:Acronym
Efficacy of Yokukansan for the treatment-resistant schizophrenia:
randomized, double-blind, placebo-controlled multicenter trial
Region
| Japan |
Condition
Condition
Treatment-Rsistant Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to assess both the efficacy and safety of Yokukansan in patients with treatment-resistant schizophrenia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Positive and Negative Syndrome Scale (PANSS)
Key secondary outcomes
Clinical Global Impression (CGI)
Global Assessment of Function (GAF)
Drug-induced Extrapyramidal Symptom Scale (DIEPSS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Yokukansan peroral administration
5-7.5g/day
Interventions/Control_2
Plasebo peroral administration
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key 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.
Key exclusion criteria
Personality disorder etc
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Horiguchi |
Organization
Shimane University School of Medicine
Division name
Psychiatry
Zip code
Address
89-1 Enyacho, Izumo, Shimane
TEL
0853-20-2262
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Miyaoka |
Organization
Shimane University School of Medicine
Division name
Psychiatry
Zip code
Address
89-1 Enyacho, Izumo, Shimane
TEL
0853-20-2262
Homepage URL
miyanyan@med.shimane-u.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Shimane University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministory of Helth, Labour and Welfare
Organization
Division
Category of Funding Organization
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
己斐ヶ丘病院
三次病院
児玉病院
リフレまえだ病院
正光会御荘病院
財団新居浜病院
豊岡台病院
牧病院
双岩病院
久米病院
西条道前病院
医療法人光佑会くろだ病院
堀江病院
正光会宇和島病院
秋田病院
冨田病院
桜木病院
聖ヶ丘病院
馬場病院
医療法人慈光会宮崎若久病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 03 | 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
| 2010 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 03 | Day |
Last modified on
| 2012 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005912
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
