UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024180 |
|---|---|
| Receipt number | R000027137 |
| Scientific Title | Activated microglia and alpha 7 nicotinic acetylchorine receptors in schizophrenia: A PET study |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2024/04/05 09:38:57 |
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Basic information
Public title
Activated microglia and alpha 7 nicotinic acetylchorine receptors in schizophrenia: A PET study
Acronym
Evaluation for activated microglia and alpha 7 nicotinic receptors using PET in schizophrenia patients
Scientific Title
Activated microglia and alpha 7 nicotinic acetylchorine receptors in schizophrenia: A PET study
Scientific Title:Acronym
Evaluation for activated microglia and alpha 7 nicotinic receptors using PET in schizophrenia patients
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the changes of the number of activated microglia and alpha 7 nichotinic receptors in schizophrenia patients compared with healthy control by using PET with 11C-DPA713 and 11C-MeQAA.
Basic objectives2
Others
Basic objectives -Others
To investigate the association between the binding potential of both 11C-DPA713 and 11C-MeQAA and the severity of schizophrenia symptoms.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The binding potential of both 11C-DPA713 and 11C-MeQAA in hippocampus and prefrontal cortex
Key secondary outcomes
cognitive function test (Cog state, TMT, stroop, VFT)
Positive and Negative Symptom Scale (PANSS)
brain MRI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
PET, 11C-DPA713 (activated microglia) 5MBq/kg iv
Interventions/Control_2
PET, 11C-MeQAA (alpha 7 nicotinic receptors) 5MBq/kg iv
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy control
- Without past or current history of psychiatric illnesses
- Non-smoker
Illnesses groups
- Diagnosed as schizophrenia on DSM-5
- Full IQ above 70 measured with Wechsler Adult Intelligent Scale-III
- Non-smoker
Key exclusion criteria
- With past or current history of serious medical illness and/or brain organic diseases
- History of alcoholics or substance abuse or addiction
- In pregnancy
- No family support
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomoyasu |
| Middle name | |
| Last name | Wakuda |
Organization
Hamamaysu University Hospital
Division name
Department of Psychiatry
Zip code
431-3192
Address
1-20-1 Handayama Higashi-ku Hmamatsu, Shizuoka
TEL
053-435-2295
wakuda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyasu |
| Middle name | |
| Last name | Wakuda |
Organization
Hamamaysu University Hospital
Division name
Department of Psychiatry
Zip code
431-3192
Address
1-20-1 Handayama Higashi-ku Hmamatsu, Shizuoka
TEL
053-435-2295
Homepage URL
wakuda@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine, Department of Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hamamatsu Photonics K.K.
Hamamatsu Medical Photonics Foundation, Hamamatsu Medical Imaging Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine Kenkyu-ka
Address
1-20-1 Handayama Higashi-ku Hmamatsu, Shizuoka
Tel
053-435-2680
rinri@hama-med.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 | 10 | Month | 01 | Day |
Related information
URL releasing protocol
The URL has not yet been created.
Publication of results
Unpublished
Result
URL related to results and publications
The URL has not yet been created.
Number of participants that the trial has enrolled
40
Results
The schizophrenia group showed an increase in the binding potential of MeQAA in the whole brain compared to the healthy group. On the other hand, the binding potential of DPA713 was not significantly different between the two groups. In the future, we plan to conduct a correlation analysis of the binding potential of MeQAA with symptom severity and the binding potential of DPA713, as well as an ROI analysis by defining regions of interest, and submit the results to an international journal.
Results date posted
| 2024 | Year | 04 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Japanese individuals with schizophrenia and healthy individuals
Participant flow
Data from 20 individuals with schizophrenia and 20 healthy subjects were used in the analysis.
Adverse events
There were no reportable adverse events among all study participants.
Outcome measures
The binding potential (BPND) of [11C](R)-MeQAA and [11C]DPA-713
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | 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 | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 27 | Day |
Last modified on
| 2024 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027137
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