UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017047 |
|---|---|
| Receipt number | 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 | 2020/07/20 14:29:33 |
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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
<Efficacy>
1) Before administration and 3 and 6 months after the start of administration:
-Change in daily dose of all antipsychotic drugs (calculated as chlorpromazine)
2) 3 months and 6 months after the start of administration:
-Dropout rate
-Monotherapy ratio
-PANSS (Positive Scale, Negative Scale, Comprehensive Psychopathology Scale)
-CGI-S
-Concomitant drugs
<Safety>
1) Before administration and 6 months after administration (final observation point/at the time of discontinuation):
-ESRS
-Adverse events
-Weight change
-Changes in blood test items:
Biochemistry (GOT, GPT, LDH, gamma-GTP, T-Bil, CPK, BUN, Cr, Na, K, Cl, CRP, T-Cho, TG, fasting (any time) blood glucose, HbA1c, prolactin), blood Arithmetic (WBC, RBC, Hb, Plt)
-ECG (change in QTc interval)
2) 1 month, 2 months, 3 months after the start of administration:
-ESRS
-Adverse events
-Weight change
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
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
niitsu@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital Clinical Research Center
Institute
Department
Personal name
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
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
| 2020 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019436
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