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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000001862
Receipt No. R000002240
Scientific Title A multicenter study on early prediction of antipsychotic response in patients with schizophrenia
Date of disclosure of the study information 2009/06/01
Last modified on 2015/04/03

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Basic information
Public title A multicenter study on early prediction of antipsychotic response in patients with schizophrenia
Acronym A multicenter study on early prediction of antipsychotic response in patients with schizophrenia
Scientific Title A multicenter study on early prediction of antipsychotic response in patients with schizophrenia
Scientific Title:Acronym A multicenter study on early prediction of antipsychotic response in patients with schizophrenia
Region
Japan

Condition
Condition schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Should we wait for response of the antipsychotic drug severeal weeks more according to conventional clinical guidelines, or replace another one, when we cannnot observe any antipsychotic effects within 2 weeks?
Basic objectives2 Others
Basic objectives -Others Early prediction of antipsychotic response: Is it possible within 2 weeks?
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The rate of remission at 4 weeks after the beginning of antipsychotics
Key secondary outcomes the Positive and Negative Syndrome Scale (PANSS) ,Clinical Global Impression Change rating scale,Global Assessment of Functioning,the Drug-induced Extrapyramidal Symptom Scale ,blood sugar, total cholesterol, triglyceride

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/risperidone
Interventions/Control_2 risperidone/olanzapine
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 schizophrenia, schizophreniform disorder, schizoaffective disorder (DSM-IV: 295.xx)
Key exclusion criteria 1) severe liver, renal, respiratory, or cardiac dysfunction
2) diabetes melitus or its history
3) women during pregnancy or nurse, women who want to get pregnant
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kotaro Hatta
Organization Juntendo University School of Medicine
Division name Department of Psychiatry
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL 03-5802-1071
Email khatta@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kotaro Hatta
Organization Juntendo University School of Medicine
Division name Department of Psychiatry
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL 03-5802-1071
Homepage URL
Email khatta@juntendo.ac.jp

Sponsor
Institute Juntendo University School 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

Other administrative information
Date of disclosure of the study information
2009 Year 06 Month 01 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
At 4 weeks, 81% of risperidone ERs (n=47) achieved >=50% response, whereas only 9% of staying risperidone ENRs (n=11) achieved >=50% response (P<0.0001). In contrast, 58% of olanzapine ERs (n=33) achieved >=50% response, whereas 25% of staying olanzapine ENRs (n=8) achieved >=50% response (P=0.12). Irrespective of the initial antipsychotics, there were no significant differences in outcomes at 4 weeks between staying ENRs and switching ENRs.
Conclusion
In newly admitted acute schizophrenic patients, non-response to risperidone using CGI-I at 2 weeks can predict subsequent clinical outcomes. However, non-response to olanzapine cannot necessarily be predicted at 2weeks.
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
2009 Year 04 Month 06 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2009 Year 11 Month 01 Day
Date of closure to data entry
2010 Year 01 Month 01 Day
Date trial data considered complete
2010 Year 02 Month 01 Day
Date analysis concluded
2010 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 04 Month 08 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=R000002240

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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