UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039357 |
|---|---|
| Receipt number | R000044769 |
| Scientific Title | Assessment of AMPA receptor density in patients with depression and bipolar disorder: a cross-sectional [11C]K-2 PET study |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2020/08/07 14:11:50 |
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Basic information
Public title
Measurement of AMPA receptor density in patients with depression and bipolar disorder: a PET study
Acronym
AMPA PET study in patients with depression and bipolar disorder
Scientific Title
Assessment of AMPA receptor density in patients with depression and bipolar disorder: a cross-sectional [11C]K-2 PET study
Scientific Title:Acronym
AMPA PET study in patients with depression and bipolar disorder
Region
| Japan |
Condition
Condition
Depression; bipolar disorder
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify brain regions that show association between AMPA receptor density and illness severity in patients with depression and bipolar disorder
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
AMPA receptor density and mood symptom scores in each of depression and bipolar disorder
Key secondary outcomes
Accuracy of differentiation of depression and bipolar disorder with the data collected in this study by using optimized machine learning program
Differences in AMPA receptor density in each voxel between depression and bipolar disorder
Adverse events during 7 days after administration of [11C]K-2
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Radiopharmaceutical [11C] K-2 is administered once, intravenously at 370 MBq for 1 minute.
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Fulfilling the criteria of depression or bipolar disorder according to the Structured Clinical Interview for DSM-IV, Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and International Statistical Classification of Diseases and Related Health Problems 10th Revison
(2) Being capable of providing informed consent
Key exclusion criteria
(1) being pregnant or breast-feeding, or wishing to become pregnant, (2) being sensitive to alcohol, (3) comorbidity of serious neurological illness, (4) history of epilepsy, (5) use of perampanel or topiramate within 4 weeks, (6) history of substance use disorder for the past 6 months, (7) positive result on urine screening of substances that cause dependence, (8) having a metal object or pace maker in the body, (9) inappropriate size of head, neck, or body for MRI scan, (10) having large tatoo, (11) suffering from serious claustrophobia, (12) presence of significant brain anomaly, (13) abnormal lab results as follows: serum creatinine level of >=1.5, AST of >=150, or ALT of >=150, (14) having participated in any clinical trial that included the use of unapproved nuclear test within 6 months, (15) having participated in any other clinical trial that included intervention, (16) being judged to be inappropriate for participation by a study medical doctor
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Miyazaki |
Organization
Yokohama City University Hospital
Division name
Anesthesiology
Zip code
236-0004
Address
3-9 Fukuura,Kanazawa-ku,Yokohama,Kanagawa,J apan
TEL
045-787-2579
johney4@hotmail.com
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Eiro |
Organization
Yokohama City University, School of Medicie
Division name
Physiology
Zip code
236-0004
Address
3-9 Fukuura,Kanazawa-ku,Yokohama,Kanagawa,Japan
TEL
045-787-2579
Homepage URL
eirotuyosi@gmail.com
Sponsor or person
Institute
Department of Physiology,Yokohama City University, School of Medicie
Institute
Department
Personal name
Funding Source
Organization
japan agency for medical research and development Strategic Research Program for Brain Science,Takeda Science Foundation,Yokohama City University Hospital advanded medical
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Keio University Hospital,Kyusyu University Hospital,Fukui University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Certified Institutional Review Board
Address
3-9 Fukuura,Kanazawa-ku,Yokohama,Kanagawa,Japan
Tel
045-370-7627
ycu_crb@yokohama-cu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs031190150
Org. issuing International ID_1
Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
横浜市立大学附属病院（神奈川県）、慶應義塾大学病院（東京都）、九州大学病院（福岡県）、福井大学病院（福井県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 10 | Month | 31 | Day |
Other
Other related information
Because this study is described in the jRCT
Management information
Registered date
| 2020 | Year | 02 | Month | 01 | Day |
Last modified on
| 2020 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044769
