UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007145 |
|---|---|
| Receipt number | R000008416 |
| 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 | 2012/04/30 |
| Last modified on | 2015/04/03 12:50:15 |
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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 switching and augmentation to early non-responders
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 switching and augmentation to early non-responders
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 antipsychotic augmentation is superior to switching to early non-responders in acute-phase schizophrenia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) rate of 40% improvement in PANSS total score
(2) all cause treatment discontinuation
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
Add olanzapine to risperidone/ Switch from risperidone to olanzapine to early non-responders
Interventions/Control_2
Add risperidone to olanzapine/Switch from olanzapine to risperidone to early non-responders
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），千葉県精神科医療センター（千葉県），東京都保健医療公社豊島病院（東京都），茨城県立友部病院（茨城県），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），国立国際医療センター国府台病院（千葉県），群馬県立精神医療センター（群馬県），福井県立病院こころの医療センター（福井県），兵庫県立光風病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 30 | 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: Sixty patients who completed 2 weeks of risperidone treatment were divided into 33 early responders (RIS-ER) and 27 ENRs (RIS+OLZ, n=14; RIS-OLZ, n=13). Although time to treatment discontinuation for any cause was significantly shorter in RIS+OLZ group (54.1 days [95% confidence interval, 41.3-67.0]) than in RIS-ER group (68.7 [61.2-76.2]; P=0.050), it was not significantly shorter in RIS-OLZ group (58.5 [43.1-73.9]) than in RIS-ER group (P=0.19). Sixty patients who completed 2 weeks of olanzapine treatment were divided into 36 early responders (OLZ-ER) and 24 ENRs (OLZ+RIS, n=11; OLZ-RIS, n=13). Although time to treatment discontinuation for any cause was significantly shorter in OLZ-RIS group (56.1 days [40.7-71.5]) than in OLZ-ER group (74.9 [68.5-81.3]; P=0.008), it was not significantly shorter in OLZ+RIS group (64.6 [49.6-79.6]) than in OLZ-ER group (P=0.20).
Conclusion: Despite the lack of pharmacokinetic investigation of dose adequacy in this study, it is possible that switching to olanzapine among ENRs to risperidone might have a small advantage over augmentation with olanzapine, while augmentation with risperidone might have a small advantage over switching to risperidone among ENRs to olanzapine. Further research is required before it would be appropriate to modify routine practice in the direction of these findings.
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
| 2012 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 22 | Day |
Date of closure to data entry
| 2013 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 26 | 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=R000008416
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