UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029593 |
|---|---|
| Receipt number | R000033716 |
| Scientific Title | Cerebral dopamine and GABA function in 22q11.2 deletion syndrome: PET and MRS study. |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2025/04/10 23:56:22 |
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Basic information
Public title
Cerebral dopamine and GABA function in 22q11.2 deletion syndrome: PET and MRS study.
Acronym
Cerebral dopamine and GABA function in 22q11.2 deletion syndrome: PET and MRS study.
Scientific Title
Cerebral dopamine and GABA function in 22q11.2 deletion syndrome: PET and MRS study.
Scientific Title:Acronym
Cerebral dopamine and GABA function in 22q11.2 deletion syndrome: PET and MRS study.
Region
| Japan |
Condition
Condition
Healthy volunteer, 22q11.2 deletion syndrome.
Classification by specialty
| Neurology | Psychiatry | Radiology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate relations between cerebral dopamine and GABA function and clinical symptoms of 22q11.2 deletion syndrome.
Basic objectives2
Others
Basic objectives -Others
To investigate relations between cerebral dopamine and GABA function and clinical symptoms of 22q11.2 deletion syndrome.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference of cerebral dopamine and GABA function between normal controls and patients with 22q11.2 deletion syndrome.
Key secondary outcomes
Correlations between cerebral dopamine and GABA function and various clinical scales
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
| Other |
Interventions/Control_1
PET/MRI/neuropsychological batteries
Interventions/Control_2
PET/MRI/neuropsychological batteries
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
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
I. Patients
20 y.o.<=Age<=55 y.o. patients with 22q11.2 deletion syndrome.
II.Healthy volunteers
20 y.o.<=Age<=55 y.o., normal subjects
Key exclusion criteria
I. Patients
1. Subjects with any organic brain disorder
2. Subjects with a severe physical complication
3. Subjects who has been taking any dopamine blocker.
4. Subjects who currently smokes
5. Subjects with metallic medical device in the body
6. Subjects with tattoo
7. Subjects with severe claustrophobia
8. Subjects who tends to suicide
9. Pregnant women
10. Subjects who was considered to be inappropriate to participate in the study
II. Healthy volunteers
1. Subjects with any psychiatric disorder
2. Subjects with any organic brain disorder
3. Subjects with severe physical complication
4. Subjects who has been taking any dopamine blocker.
5. Subjects who currently smokes
6. Subjects with metallic medical device in the body
7. Subjects with tattoo
8. Subjects with severe claustrophobia
9. Pregnant women
10. Subjects who has participated in other study in recent 6 months.
11. Subjects who was considered to be inappropriate to participate in the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Takahata |
Organization
National Institute of Radiological Sciences
Division name
Department of Functional Brain Imaging Research
Zip code
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
81432063025
takahata.keisuke@qst.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Takahata |
Organization
National Institute of Radiological Sciences
Division name
Department of Functional Brain Imaging Research
Zip code
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
81432063025
Homepage URL
takahata.keisuke@qst.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
National Institute of Radiological Sciences
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
Address
Tel
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
| 2017 | Year | 11 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2017 | Year | 10 | Month | 17 | Day |
Last modified on
| 2025 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033716
