UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002076 |
|---|---|
| Receipt number | R000002489 |
| Scientific Title | Aripiprazole research over schizophrenia patients (both on first episode and recurrence) about its efficacy and influence on cognitive function |
| Date of disclosure of the study information | 2009/06/14 |
| Last modified on | 2012/05/11 09:19:35 |
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Basic information
Public title
Aripiprazole research over schizophrenia patients (both on first episode and recurrence) about its efficacy and influence on cognitive function
Acronym
Aripiprazole research over schizophrenia patients (both on first episode and recurrence) about its efficacy and influence on cognitive function
Scientific Title
Aripiprazole research over schizophrenia patients (both on first episode and recurrence) about its efficacy and influence on cognitive function
Scientific Title:Acronym
Aripiprazole research over schizophrenia patients (both on first episode and recurrence) about its efficacy and influence on cognitive function
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to get more information about efficacy of aripiprazole, then help to make clear about the mechanism of schizophrenia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
apply neuropsychological tasks and evaluate the difference of the score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Monotherapy of aripiprazole:
Estimate 8 weeks after the beginning, then follow up until 24 weeks (till 31/Mar/2012).
About the dosage of aripiprazole, start at 6-12mg/day, then maintain at 6-30mg/day.
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
schizophrenia patients diagnosed by DSM-4
Key exclusion criteria
patients using epinephrine
patients with allergic reaction to aripiprazole before
diabetic patients and patients who have history of suffering from diabetes
patients with (or, with the possibility of) pregnancy
patients taking other antipsychotics
other patients not suitable for this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiya Murai |
Organization
Kyoto University Hospital
Division name
Department of Neuropsychiatry
Zip code
Address
54 Shogoin-Kawahara-cho Sakyo-ku Kyoto
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University Hospital
Division name
Department of Neuropsychiatry
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Scholarship department of neuropsychiatry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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 | 14 | 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 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
Completed
Date of protocol fixation
| 2009 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 14 | Day |
Last modified on
| 2012 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002489
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
