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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000007145
Receipt No. 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

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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
Email 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
Email khatta@juntendo.ac.jp

Sponsor
Institute Juntendo University Faculty of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008416

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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