UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021175 |
|---|---|
| Receipt number | R000024417 |
| Scientific Title | Dopamine D2 and D3 receptors occupancy evaluation study of continuous antipsychotic drug administration by positron emission tomography |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2019/12/19 17:06:11 |
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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
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
amtateno@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
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
Nippon Medical School Hospital Institutional Review Board
Address
1-1-5, Sendagi, Bunkyo-Ku, Tokyo, Japan
Tel
+81-3-3822-2131
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024417
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