UMIN-CTR Clinical Trial

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

Major depressive disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

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

Email

helsinki@nirs.go.jp

Institute

National Institute of Radiological Sciences

Institute

Department

Personal name

Organization

National Institute of Radiological Sciences

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

06

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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