UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020669 |
|---|---|
| Receipt number | R000023855 |
| Scientific Title | An open trial regarding the safety and efficacy of blonanserin for patients with gambling disorder |
| Date of disclosure of the study information | 2016/01/21 |
| Last modified on | 2017/04/27 09:22:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
An open trial regarding the safety and efficacy of blonanserin for patients with gambling disorder
Acronym
Open trial of blonanserin for gambling disorder
Scientific Title
An open trial regarding the safety and efficacy of blonanserin for patients with gambling disorder
Scientific Title:Acronym
Open trial of blonanserin for gambling disorder
Region
| Japan |
Condition
Condition
Gambling disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety and efficacy of blonanserin for patients with gambling disorder
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall severity of DIEPSS at 8 weeks
Key secondary outcomes
The change of the scores in GSAS, PG-YBOCS, BIS-11, and CGI-C at 8 weeks
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
Blonanserin, 2-12 mg/day, 8 weeks
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Gambling disorder as defined by DSM-5
2. Outpatients of Chiba University Hospital
3. 20<= age at consent < 65
4. 5>= SOGS score
Key exclusion criteria
1. Incompetent
2. Pregnant, nursing, or being expected as so
3. F2 or F0 by ICD-10
4. uncontrolled physical illness
5. taking antipsychotic drugs within 28 days before
6. taking prohibited with blonanserin
7. history of allergic reaction for blonanserin
8. history of malignant syndrome or tardive dyskinesia caused by antipsychotic drugs
9. participated other clinical trials within 3 month before
10. 15 >= MADRS
11. 15 >= YMRS
12. 3 >= overall severity of DIEPSS
13. history of suicide attempt within one years before
14. contraindicated by the doctor in charge
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Shiina |
Organization
Chiba University
Division name
Department of psychiatry, Graduate school of medicine
Zip code
Address
Inohana 1-8-1, Chuoh-ku, Chiba-shi
TEL
+81-42-222-7171
shiina-akihiro@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Shiina |
Organization
Chiba University
Division name
Department of psychiatry, Graduate school of medicine
Zip code
Address
Inohana 1-8-1, Chuoh-ku, Chiba-shi
TEL
+81-42-222-7171
Homepage URL
shiina-akihiro@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Council for Addiction Behavior Studies
Organization
Division
Category of Funding Organization
Non profit foundation
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
YES
Study ID_1
G27039
Org. issuing International ID_1
Chiba University Hospital Clinical Research Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
千葉大学医学部附属病院(千葉県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 21 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 22 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 22 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 20 | Day |
Last modified on
| 2017 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023855
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
