UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008217 |
|---|---|
| Receipt number | R000009684 |
| Scientific Title | Effect of blonanserin on cognitive impairment in schizophrenic patient-non-blinded, randomized, comparative study with olanzapine |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2013/04/03 13:13:07 |
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Basic information
Public title
Effect of blonanserin on cognitive impairment in schizophrenic patient-non-blinded, randomized, comparative study with olanzapine
Acronym
Effect of blonanserin on cognitive impairment in schizophrenic patient
Scientific Title
Effect of blonanserin on cognitive impairment in schizophrenic patient-non-blinded, randomized, comparative study with olanzapine
Scientific Title:Acronym
Effect of blonanserin on cognitive impairment in schizophrenic patient
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the difference between blonanserin and olanzapine on the effect of improvement of cognitive function in patients with schizophrenia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
BACS-J
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
antipsychotics(blonanserin)
Interventions/Control_2
antipsychotics(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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Schizophrenic patient(ICD-10,DSM-4-TR)
PANSS total score over 61 points
Clinical Global Impressions(CGI) over 4 points
Regardless of the sex, age and inpatient or outpatient
Key exclusion criteria
blonanserin or olanzapine administration
(within 1 month before trial)
clozapine prescription
(within 3 month before trial)
coma
seizure disorders,brain organic disease
serious complication
drug,alcohol abuse
diabetes mellitus
pregnancy,possibility of pregnancy
dementia
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Sasada |
Organization
Faculty of Medical Science, Kobe University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
Address
7-5-1, Kusunoki-cho, Chuou-ku, Kobe , Japan
TEL
078-382-6065
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Sasada |
Organization
Faculty of Medical Science, Kobe University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
Address
TEL
078-382-6065
Homepage URL
Sponsor or person
Institute
Department of Psychiatry, Faculty of Medical Science, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Psychiatry, Faculty of Medical Science, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
神戸大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 20 | Day |
Last modified on
| 2013 | 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=R000009684
