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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024180
Receipt No. R000027137
Scientific Title Clinical study of evaluated the changes of 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 2019/04/01

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Basic information
Public title Clinical study of evaluated the changes of 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 Clinical study of evaluated the changes of 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) 3MBq/kg iv
Interventions/Control_2 PET, 11C-MeQAA (alpha 7 nicotinic receptors) 3MBq/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 44

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
Email 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
Email wakuda@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine, Department of Psychiatry
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
Email 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
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 Open public 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
2021 Year 07 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
2016 Year 09 Month 27 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027137

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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