UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008251 |
|---|---|
| Receipt number | R000009689 |
| Scientific Title | Occupancy of norepinephrine transporter by duloxetine measured using positron emission tomography with [18F]FMeNER-D2 |
| Date of disclosure of the study information | 2012/06/27 |
| Last modified on | 2012/06/25 16:41:35 |
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Basic information
Public title
Occupancy of norepinephrine transporter by duloxetine measured using positron emission tomography with [18F]FMeNER-D2
Acronym
Norepinephrine transporter occupancy by duloxetine
Scientific Title
Occupancy of norepinephrine transporter by duloxetine measured using positron emission tomography with [18F]FMeNER-D2
Scientific Title:Acronym
Norepinephrine transporter occupancy by duloxetine
Region
| Japan |
Condition
Condition
Major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to measure occupancy of the norepinephrine transporter in the brain by an antidepressant, duloxetine, by using positron emission tomography (PET) with [18F]FMeNER-D2 in healthy subjects and patients with major depressive disorder (MDD). PET scans will be performed twice before (at baseline) and after duloxetine treatment (for healthy subjects, single doses of duloxetine will be administered, and for patients with MDD, clinical doses of duloxetine will be administered for 4-8 weeks) on different days. We will also perform functional magnetic resonance imaging (fMRI) and psychological tests on the same day the PET scans are performed.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between the doses of duloxetine and norepinephrine transporter occupancy, and its relevance to changes in clinical symptoms as well as brain functions measured using fMRI and psychological tests
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Clinical doses of single administration of duloxetine (Healthy subjects)
Interventions/Control_2
Clinical doses of repeated administration of duloxetine (MDD patients)
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy subjects:
Do not have any psychiatric disorders currently, nor have had similar disorders in the past
Able to understand an explanatory document and give consent
Patients:
Diagnosed as having MDD by using DSM-IV-TR and considered suitable for receiving duloxetine treatment
Only duloxetine is allowed as an antidepressant. The concomitant use of benzodiazepines as anxiolytic and hypnotic drugs is also allowed.
Key exclusion criteria
Healthy subjects:
Pregnant or possible to become pregnant
Currently breastfeeding
Have a cardiac pacemaker or other metals in the body, such as brain clip or bolt
Participating in other studies involving the use of nuclear medicine within the past 6 months, in terms of radiation safety
Other: judged inappropriate as a subject by the investigator
Patients:
Severe suicidal tendency
Presence of other comorbid psychiatric disorders
Have taken antidepressants and/or antipsychotic drugs within 1 month prior to the first examination
Have organic brain diseases
Have current severe physical diseases
Pregnant or possible to become pregnant
Currently breastfeeding
Have a cardiac pacemaker or other metals in the body, such as brain clip or bolt
Other: judged inappropriate as a subject by the investigator
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Harumasa Takano |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Institute of Radiological Sciences
Division name
A study ethic plan support room
Zip code
Address
TEL
Homepage URL
helsinki@nirs.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
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
| 2012 | Year | 06 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 25 | Day |
Last modified on
| 2012 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009689
