Major depressive disorder
Conditions
Interventions
Clinical doses of single administration of duloxetine (Healthy subjects)
Clinical doses of repeated administration of duloxetine (MDD patients)
Sponsors
National Institute of Radiological Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Outcome results
None listed