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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name