UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006586 |
|---|---|
| Receipt number | R000007064 |
| Scientific Title | Study of emotion and fatigue using novel imaging for aromatase |
| Date of disclosure of the study information | 2011/10/21 |
| Last modified on | 2023/02/17 18:01:51 |
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Basic information
Public title
Study of emotion and fatigue using novel imaging for aromatase
Acronym
Study of emotion and fatigue by imaging aromatase
Scientific Title
Study of emotion and fatigue using novel imaging for aromatase
Scientific Title:Acronym
Study of emotion and fatigue by imaging aromatase
Region
| Japan |
Condition
Condition
Healthy subjects, eating disorder associated with aggression, chronic fatigue syndrome
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Psychosomatic Internal Medicine |
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the involvement of aromatase, which produces estrogens, to fatigue and aggression.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Binding potential of 11C-cetrozole to aromatase measured using PET
Key secondary outcomes
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
3
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
11C-cetrozole PET
Interventions/Control_2
11C-cetrozole PET
Interventions/Control_3
11C-cetrozole PET
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with Chronic fatigue syndrome or eating disorder associated with aggression diagnosed in Osaka City University Hospital and healthy subjects, who give informed consent.
Key exclusion criteria
Participants
1) with past or currrent history of serious medical illness and/or brain organic desease
2) with pregnancy women
3) who take central nerve system acting drugs, such as autonomic drugs and antidepressants
4) who is contradicated for the use of MRI
5) who are judged as not suitable for participation in this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | TANAKA |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of System Neuroscience
Zip code
5450051
Address
1-4-3 Asahimachi, Abeno-ku, Osaka-shi, Osaka 545-8585, Japan
TEL
06-6645-3611
kayo.takahashi@riken.jp
Public contact
Name of contact person
| 1st name | Kayo |
| Middle name | |
| Last name | Takahashi |
Organization
RIKEN
Division name
Center for Molecular Imaging Science
Zip code
6500047
Address
6-7-3 Minatojima Minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, Japan
TEL
078-304-7124
Homepage URL
kayo.takahashi@riken.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Takeda science foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Osaka City University Graduate School of Medicine
Address
1-2-7 Asahimachi Abeno-ku Osaka
Tel
06-6645-3435
ethics@med.osaka-cu.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
大阪市立大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 21 | Day |
Related information
URL releasing protocol
https://www.nature.com/articles/s41598-018-35065-4
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-018-35065-4
Number of participants that the trial has enrolled
24
Results
Strong accumulation of 11C-cetrozole was detected in the thalamus, hypothalamus, amygdala, and medulla. In females, there was an association between aromatase levels in subcortical regions such as the amygdala and hypothalamus and personality traits such as aggression, etc. In contrast, in males, associations were found between aromatase levels in the cortex and harm avoidance, etc. The association between aromatase levels in the thalamus and cooperativeness was similar for both sexes.
Results date posted
| 2023 | Year | 02 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Female average age was 34.7, and male was 31.7yrs,
Participants were excluded if they had past or current serious medical illnesses and/or organic brain diseases or if they took drugs actin on the central nervous system.
All females were not taking oral contraceptives and had regular menstrual cycle.
Participant flow
All participants provided written informed consent for participation in the study.
Each subject completed the validated Japanese version of the Buss-Perry Aggression Questionnaire and Temperament and Character Inventory before PET scan.
PET scan was performed for 60 min.
Adverse events
N/A
Outcome measures
PET data
aggression score
personality traits
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 21 | Day |
Last modified on
| 2023 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007064
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