UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004398 |
|---|---|
| Receipt number | R000005259 |
| Scientific Title | Open label randomized trial of treatment by perospirone and aripiprazole for schizophrenia patients considering the drug susceptibility gene |
| Date of disclosure of the study information | 2010/10/22 |
| Last modified on | 2017/10/23 10:59:42 |
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Basic information
Public title
Open label randomized trial of treatment by perospirone and aripiprazole for schizophrenia patients considering the drug susceptibility gene
Acronym
Controlled clinical comparison of perospirone and aripiprazole considering the drug susceptibility gene
Scientific Title
Open label randomized trial of treatment by perospirone and aripiprazole for schizophrenia patients considering the drug susceptibility gene
Scientific Title:Acronym
Controlled clinical comparison of perospirone and aripiprazole considering the drug susceptibility gene
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To compare the therapeutic efficacy and tolerability of perospirone and aripiprazole in patients with schizophrenia considering the drug susceptibility gene.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Positive and Negative Syndrome Scale
Gene polymorphism
Key secondary outcomes
Drug-Induced Extrapyramidal Symptoms Scale
Barnes Akathisia Scale
Clinical Global Impression
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Perospirone
Interventions/Control_2
Aripiprazole
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
| 15 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients (inpatients and outpatients) over 15 years of age, who were diagnosed with schizophrenia (according to the DSM-IV criteria) and were required to have scores PANSS total score 60 or more, and a score 4 or more on at least two of the PANSS-positive items assessing delusions, hallucinatory behavior or conceptual disorganization, were eligible. Patients for whom the total dose of antipsychotics (haloperidol equivalent dose) is lower than 12.0 mg/day at screening.
Key exclusion criteria
Patient with coma; under the depressant by barbiturates, received perospirone or aripiprazole within 4 weeks (30 days), participated in a clinical study or post-marketing clinical study within 12 months (180 days), were pregnant or may become pregnant or nursing, history of drug and alcohol abuse, neuroleptic malignant syndrome, water intoxication, known hypersensitivity to study drugs, significant risk of suicide, currently epinephrine administration precluded entry into the study, and patients considered as inadequate by investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiteru Takekita |
Organization
Kansai Medical University
Division name
Department of Neuropsychiatry
Zip code
Address
10-15 fumizono-cho, Moriguchi Osaka, 570-8506, Japan
TEL
06-6992-1001
takekity@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiteru Takekita |
Organization
Kansai Medical University
Division name
Department of Neuropsychiatry
Zip code
Address
10-15 fumizono-cho, Moriguchi Osaka, 570-8506, Japan
TEL
06-6992-1001
Homepage URL
takekity@takii.kmu.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Dainippon Sumitomo Pharma Co., Ltd.
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hyogo University of Health Sciences
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
関西医科大学附属滝井病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | 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 | 12 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 18 | Day |
Last modified on
| 2017 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005259
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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