UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001862 |
|---|---|
| Receipt number | 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 12:39:51 |
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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
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
khatta@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002240
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