UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An open trial regarding the safety and efficacy of blonanserin for patients with gambling disorder
Title of the study (Brief title)	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	Akihiro Shiina
Organization	Chiba University
Division name	Department of psychiatry, Graduate school of medicine
Address	Inohana 1-8-1, Chuoh-ku, Chiba-shi
TEL	+81-42-222-7171
Email	shiina-akihiro@faculty.chiba-u.jp

Public contact
Name of contact person	Akihiro Shiina
Organization	Chiba University
Division name	Department of psychiatry, Graduate school of medicine
Address	Inohana 1-8-1, Chuoh-ku, Chiba-shi
TEL	+81-42-222-7171
Homepage URL
Email	shiina-akihiro@faculty.chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023855