UMIN-CTR Clinical Trial

Basic information
Public title	Dopamine D2 and D3 receptors occupancy evaluation study of continuous antipsychotic drug administration by positron emission tomography
Acronym	Dopamine D2 and D3 receptors occupancy evaluation study of continuous antipsychotic drug administration
Scientific Title	Dopamine D2 and D3 receptors occupancy evaluation study of continuous antipsychotic drug administration by positron emission tomography
Scientific Title:Acronym	Dopamine D2 and D3 receptors occupancy evaluation study of continuous antipsychotic drug administration
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the dopamine D2 and D3 receptor occupancy by continuous antipsychotics administration.
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the dopamine D2 and D3 receptor occupancy of antipsychotics will be assessed after taking antipsychotics for 2 weeks.
Key secondary outcomes	blood concentration, MRI, neuropsychological test

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	1)PET, MRI, blood concentration 2)blonanserin 8 to 24mg po, for 2 weeks, PET, MRI, blood concentration
Interventions/Control_2	1)PET, MRI, blood concentration 2)olanzapine 2.5 to 20mg po, for 2 weeks, PET, MRI, blood concentration
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	- Patinet who was diagnosed as schizophrenia by DSM-IV-TR - Patinet with PANSS score is less than 120 at the screening - Patient who has been taking single administration of olanzapine, the dose was not changed at least more than 2 weeks, at least 4 weeks before the test. Or drug-naive patient. - Subjects who have the ability to provide informed consent and adhere to the protocol.
Key exclusion criteria	- with past or current history of serious medical illness and/or brain organic diseases - subject who is contraindicated for the use of MRI - with past or current history ofsevere liver disease, kidney disease, heart disease, allergy, or severe drug allergy - contraindication for blonanserin - treated by electroconvulsive therapy within 3 months before the screening. - taking tandspirone at the screening. - subject who are judged as not suitable for participation in this study
Target sample size	13

Research contact person
Name of lead principal investigator	1st name Yoshiro Middle name Last name Okubo
Organization	Nippon Medical School
Division name	Department of Neuropsychiatry
Zip code	113-8602
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL	+81-3-3822-2131
Email	okubo-y@nms.ac.jp

Public contact
Name of contact person	1st name Amane Middle name Last name Tateno
Organization	Nippon Medical School
Division name	Department of Neuropsychiatry
Zip code	113-8602
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL	+81-3-3822-2131
Homepage URL
Email	amtateno@nms.ac.jp

Sponsor
Institute	Nippon Medical School
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	Nippon Medical School Hospital Institutional Review Board
Address	1-1-5, Sendagi, Bunkyo-Ku, Tokyo, Japan
Tel	+81-3-3822-2131
Email	clinicaltrial@nms.ac.jp

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	2016 Year 03 Month 01 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 25 Day
Date of IRB	2016 Year 02 Month 15 Day
Anticipated trial start date	2016 Year 03 Month 03 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 04 Month 30 Day
Date trial data considered complete	2018 Year 05 Month 31 Day
Date analysis concluded	2018 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2016 Year 02 Month 24 Day
Last modified on	2019 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024417