UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022849 |
|---|---|
| Receipt number | R000026333 |
| Scientific Title | Evaluation study of serotonin 1B receptors in mental disorders by positron emission tomography |
| Date of disclosure of the study information | 2016/06/27 |
| Last modified on | 2024/12/31 12:34:10 |
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Basic information
Public title
Evaluation study of serotonin 1B receptors in mental disorders by positron emission tomography
Acronym
Evaluation study of serotonin 1B receptors in mental disorders
Scientific Title
Evaluation study of serotonin 1B receptors in mental disorders by positron emission tomography
Scientific Title:Acronym
Evaluation study of serotonin 1B receptors in mental disorders
Region
| Japan |
Condition
Condition
Organic and symptomatic mental disorders, Schizophrenia, mood disorders, anxiety disorders, nonorganic insomnia
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the serotonin 1B receptors of mental disorders
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
evaluation of the serotonin 1B receptor of mental disorders by PET
Key secondary outcomes
cognitive function by neuropsychological test, MRI, blood concentration, sleep state
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
PET ([11C]AZ20149369 370MBq), MRI, blood concentration
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
- Patients who diagnosed as F0, F2, F3, F4, F5 by ICD-10
- healthy control
Key exclusion criteria
- with past or current history of serious medical illness and/or brain organic diseases
- subject who is contraindicated for the use of MRI
- with past or current history ofsevere liver disease, kidney disease, heart disease, allergy, or severe drug allergy
- pregnant woman
- subject who are judged as not suitable for participation in this study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yoshiro |
| Middle name | |
| Last name | Okubo |
Organization
Nippon Medical School
Division name
Department of Neuropsychiatry
Zip code
113-8602
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-3822-2131
okubo-y@nms.ac.jp
Public contact
Name of contact person
| 1st name | Amane |
| Middle name | |
| Last name | Tateno |
Organization
Nippon Medical School
Division name
Department of Neuropsychiatry
Zip code
113-8602
Address
1-1-5 Sendagi, Bunkyo-ku , Tokyo, Japan
TEL
+81-3-3822-2131
Homepage URL
amtateno@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Hospital Institutional Review Board
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
Tel
+81-3-3822-2131
clinicaltrial@nms.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 | 06 | Month | 27 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0165032721007394?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0165032721007394?via%3Dihub
Number of participants that the trial has enrolled
45
Results
Thirteen patients completed the study according to protocol. 5-HT1B receptor binding in hippocampus increased with 30 % after ECT (p=0.021). Using linear mixed effects modelling, we observed increases in 5-HT1B receptor binding following ECT with a moderate to large effect size, which did not differ significantly between regions. In an exploratory analysis, strong correlations between changes in 5-HT1B receptor binding and agitation scores on the Hamilton Depression Rating Scale after ECT were observed.
Results date posted
| 2024 | Year | 12 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients admitted to Nippon Medical School Hospital (NMSH) with MDE as an indication for ECT were eligible for the study.
Based on clinical interviews and medical histories 14 patients met the DSM-IV criteria for major depressive disorder and one patient for bipolar disorder.
Exclusion criteria were: psychotic disorder, substance abuse, organic brain disorder or brain damage, ongoing treatment with drugs targeting 5-HT1B receptors, pregnancy, age: <20 and >80, metal implants, and claustrophobia.
Healthy control subjects matched for sex and age were recruited.
Participant flow
Recruitment in writing and on the website
Written explanation and consent
Psychiatric symptom evaluation and eligibility confirmation
Perform PET and MRI examinations
Adverse events
none
Outcome measures
Hamilton Depression Rating Scale
Brain Morphometry by MRI
Serotonin 1B receptor binding capacity by PET
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 23 | Day |
Last modified on
| 2024 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026333
