UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005526 |
|---|---|
| Receipt number | R000006551 |
| Scientific Title | Psychiatric emergency multi-center randomized clinical trial on unanswered questions of pharmacotherapy in acute-phase schizophrenia |
| Date of disclosure of the study information | 2011/05/31 |
| Last modified on | 2015/04/03 12:44:36 |
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Basic information
Public title
Psychiatric emergency multi-center randomized clinical trial on unanswered questions of pharmacotherapy in acute-phase schizophrenia
Acronym
Psychiatric emergency multi-center RCT of antipsychotic high dose
Scientific Title
Psychiatric emergency multi-center randomized clinical trial on unanswered questions of pharmacotherapy in acute-phase schizophrenia
Scientific Title:Acronym
Psychiatric emergency multi-center RCT of antipsychotic high dose
Region
| Japan |
Condition
Condition
schizophrenia, schizophreniform disorder, schizoafective disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our aim is to examine whether olanzapine is superior to risperidone if we can use up to 40mg of olanzapine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) rate of 50% improvement in PANSS total score
(2) rate of treatment discontinuation for any cause
Key secondary outcomes
(1) torelability (DIEPSS, rate of treatment discontinuation for adverse event), change in vital signs and weight
(2) improvement in symptoms (PANSS total, subscales, CGI, GAF)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
olanzapine up to 40mg
Interventions/Control_2
risperidone up to 12mg
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who are admitted to psychiatric emergnecy hospitals due to acute-psychotic state, diagnosed as DSM-IV: 295.xx
Key exclusion criteria
1) severe liver, renal, heart, or respiratory dysfunction
2) diabetes mellitus, or its history
3) pregnant, nursing, or desiring to be pregnant
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kotaro Hatta |
Organization
Juntendo University Faculty of Medicine
Division name
Juntendo University Nerima Hospital
Zip code
Address
3-1-10 Takanodai, Nerima-ku, Tokyo 177-8521
TEL
03-5923-3111
khatta@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kotaro Hatta |
Organization
Juntendo University Faculty of Medicine
Division name
Juntendo University Nerima Hospital
Zip code
Address
3-1-10 Takanodai, Nerima-ku, Tokyo 177-8521
TEL
03-5923-3111
Homepage URL
khatta@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
the Ministry of Health, Welfare, and Labor of the Japanese Government
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
埼玉県立精神医療センター（埼玉県），土佐病院（高知県），さわ病院（大阪府），三重県立こころの医療センター（三重県），東京武蔵野病院（東京都），静岡県こころの医療センター（静岡県），東京都保健医療公社豊島病院（東京都），旭川圭泉会病院（北海道），ほくとクリニック病院（大阪府），成増厚生病院（東京都），成仁病院（東京都），肥前精神医療センター（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results: It was not conclusive about the primary outcome measure because the number of patients allocated to each treatment group was approximately 60% of the required number of patients set by power analysis. The Negative score of the Positive and Negative Syndrome Scale was significantly higher in high-dose patients than in conventional-dose patients. Serum olanzapine concentrations at the timing of oral 20 mg/day could be obtained from 5 out of 7 patients who subsequently required high-dose olanzapine. All values reached a therapeutic range of 20-50 ng/mL, and the mean value was 47.876 (SD 21.546) ng/mL.
Conclusion: The present study has shown evidence that the reason for requiring high-dose olanzapine cannot be explained by pharmacokinetics for the first time.
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
Main results already published
Date of protocol fixation
| 2011 | Year | 05 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 28 | Day |
Last modified on
| 2015 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006551
