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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017047
Receipt No. R000019436
Scientific Title A randomized, open-label clinical trial on the efficacy of blonanserin and olanzapine in patients with schizophrenia and dopamine supersensitivity psychosis
Date of disclosure of the study information 2015/04/10
Last modified on 2019/03/31

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Basic information
Public title A randomized, open-label clinical trial on the efficacy of blonanserin and olanzapine in patients with schizophrenia and dopamine supersensitivity psychosis
Acronym Replacement with the Optimal Antipsychotic for Dopamine Supersensitivity Study (ROADS Study)
Scientific Title A randomized, open-label clinical trial on the efficacy of blonanserin and olanzapine in patients with schizophrenia and dopamine supersensitivity psychosis
Scientific Title:Acronym Replacement with the Optimal Antipsychotic for Dopamine Supersensitivity Study (ROADS Study)
Region
Japan

Condition
Condition Schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of blonanserin compared with olanzapine in patients with dopamine supersensitivity psychosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes Change in total score of the Positive and Negative Symptoms Scale (PANSS) between baseline and endpoint (6 months)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Blonanserin as add-on therapy
Interventions/Control_2 Olanzapine as add-on therapy
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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1)Diagnosed as a schizophrenia (DSM-IV-TR)
2)[Criteria for DSP]Treated with antipsychotics for at least 3 months
3)[Criteria for DSP] Relapse/exacerbation of psychosis in the past year under any of the following conditions:
a) Relapse/exacerbation within 6 weeks after reduction/discontinuance/non-adherence of oral antipsychotics
b) Relapse/exacerbation within 3 months after reduction/discontinuance/non-adherence of long acting injectable antipsychotics
c) Failure to control relapse/exacerbation using 20% increased dose of antipsychotics
d) New symptoms/severe exacerbation induced by reduction/discontinuance/non-adherence/replacement of antipsychotics
4) Total score of PANSS at baseline >= 78
5) Stable antipsychotic treatment for the 4 weeks before providing informed consent
6) Providing an informed consent
Key exclusion criteria 1)[Criteria for DSP] First episode schizophrenia
2)[Criteria for DSP] Unstable and continuous severe psychotic symptoms under antipsychotic treatment for more than 3 months
3))[Criteria for DSP] Deficit syndrome
4)Contraindication to blonanserin/olanzapine
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Masaomi
Middle name
Last name Iyo
Organization Chiba University Graduate School of Medicine
Division name Psychiatry
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL +81-(0)43-226-2148
Email iyom@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Tomihisa
Middle name
Last name Niitsu
Organization Chiba University Graduate School of Medicine
Division name Department of Psychiatry
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL +81-(0)43-226-2148
Homepage URL
Email niitsu@chiba-u.jp

Sponsor
Institute Chiba University Hospital Clinical Research Center
Institute
Department

Funding Source
Organization Sumitomo Dainippon Pharma Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Chiba University Hospital, IRB
Address 1-8-1 Inohana, Chuo-ku, Chiba
Tel 043-222-7171
Email chibacrc@mac.com

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
2015 Year 04 Month 10 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 61
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
2015 Year 02 Month 19 Day
Date of IRB
2015 Year 02 Month 19 Day
Anticipated trial start date
2015 Year 04 Month 16 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
2018 Year 11 Month 30 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 05 Day
Last modified on
2019 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019436

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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