UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038171 |
|---|---|
| Receipt number | R000043512 |
| Scientific Title | Activated microglia and alpha 7 nicotinic acetylchorine receptors in schizophrenia: A PET study (for smoker) |
| Date of disclosure of the study information | 2019/10/07 |
| Last modified on | 2024/09/02 20:56:56 |
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Basic information
Public title
Activated microglia and alpha 7 nicotinic acetylchorine receptors in schizophrenia: A PET study (for smoker)
Acronym
Evaluation for activated microglia and alpha 7 nicotinic receptors using PET in schizophrenia (for smoker)
Scientific Title
Activated microglia and alpha 7 nicotinic acetylchorine receptors in schizophrenia: A PET study (for smoker)
Scientific Title:Acronym
Evaluation for activated microglia and alpha 7 nicotinic receptors using PET in schizophrenia patients (for smoker)
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the binding potential of the activated microglia and alpha 7 nichotinic receptors in smoking patients with schizophrenia compared with non-smoker healthy control and patients with schizophrenia by using PET with 11C-DPA713 and 11C-MeQAA.
Basic objectives2
Others
Basic objectives -Others
To evaluate the differences between 11C-DPA713 and 11C-MeQAA binding potentials in schizophrenia with and without smoking.
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)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Diagnosed as schizophrenia on DSM-5
- Full IQ above 70 measured with Wechsler Adult Intelligent Scale-III
- 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
- Taking antiallergic or anticholinergic drugs
- Difficult for taking MRI imaging
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomoyasu |
| Middle name | |
| Last name | Wakuda |
Organization
Hamamatsu University Hospital
Division name
Department of Psychiatry
Zip code
4313192
Address
1-20-1 Handayama Higashi-ku Hmamatsu, Shizuoka
TEL
+81534352295
wakuda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyasu |
| Middle name | |
| Last name | Wakuda |
Organization
Hamamatsu University Hospital
Division name
Department of Psychiatry
Zip code
431-3192
Address
1-20-1 Handayama, Higashiku, Hamamatsu
TEL
0534352295
Homepage URL
wakuda@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University Hospital
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
Address
1-20-1 Handayama, Higashiku, Hamamatsu
Tel
0534352680
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
| 2019 | Year | 10 | Month | 07 | 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
0
Results
The number of study participants was 0.
Results date posted
| 2024 | Year | 09 | Month | 02 | Day |
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
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 01 | Day |
Last modified on
| 2024 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043512
