UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011194 |
|---|---|
| Receipt number | R000013116 |
| Scientific Title | Efficacy and tolerability of blonanserin versus aripiprazole in Japanese patients with psychotic disorder: a randomized, masked-rater trial |
| Date of disclosure of the study information | 2013/07/16 |
| Last modified on | 2017/01/27 12:00:27 |
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Basic information
Public title
Efficacy and tolerability of blonanserin versus aripiprazole in Japanese patients with psychotic disorder: a randomized, masked-rater trial
Acronym
A randomized controlled trial of blonanserin versus aripiprazole in psychotic disorder
Scientific Title
Efficacy and tolerability of blonanserin versus aripiprazole in Japanese patients with psychotic disorder: a randomized, masked-rater trial
Scientific Title:Acronym
A randomized controlled trial of blonanserin versus aripiprazole in psychotic disorder
Region
| Japan |
Condition
Condition
psychotic disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the therapeutic efficacy and tolerability of blonanserin and aripiprazole in patients with psychotic disorder
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
PANSS
Key secondary outcomes
CGI
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 not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Blonanserin
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Schizophrenia, schizoaffective disorder, schizophreniform disorder based on DSM-4-TR
The patients did not take any antisychotics for more than 2 weeks
Key exclusion criteria
Patients with coma.
Patients take barbiturate, anesthetic, adrenaline, psychostimulant or.and alocohol.
Patients with allergies to blonanserin and aripiprazole
Patients who are pregnant or may become pregnant
Patients with personality disorder or mental retardation.
ients with dementina.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nakao Iwata |
Organization
Fujita Health University School of Medicine
Division name
Department of Psychiatry
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi. 470-1192. Japan
TEL
0562939250
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taro Kishi |
Organization
Fujita Health University School of Medicine
Division name
Department of Psychiatry
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi. 470-1192. Japan
TEL
0562939250
Homepage URL
tarok@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
The Okehazama Hospital
The Jindai Hospital
The St. Cross Hospital
The Toyota Memorial Hospital
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
藤田保健衛生大学
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.dovepress.com/a-randomized-trial-of-aripiprazole-vs-blonanserin-for-the-treatment-of-pee
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
| 2013 | Year | 07 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 08 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 16 | Day |
Last modified on
| 2017 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013116
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
