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 2021/04/12 23:05:01

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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

Email

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


Email

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



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

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

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


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

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

2021 Year 04 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043512


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name