Major Depressive Disorder
Conditions
Brief summary
The purpose of this study is to evaluate how taking duloxetine 60mg every day affects the transfer of two normal body chemicals, 3,4-dihydroxyphenylglycol (DHPG) and norepinephrine (NE), across cells in blood and cerebrospinal fluid.
Interventions
DRUGEscitalopram
DRUGPlacebo
DRUGDuloxetine
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy subjects between the ages of 18-65 years are nonsmokers or are willing to refrain from smoking and are not taking concomitant medications which may inhibit or induce CYP1A2 or CYPD6 or is an MAOI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentrations of DHPG and NE in plasma (in sitting and standing positions), urine, and CSF after multiple daily doses (steady state). | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of duloxetine versus escitalopram on ex vivo reuptake inhibition of NE and F-hydroxytryptamine (5-HT) in serum and relationship to exposure. | — |
| Effect of duloxetine versus escitalopram on heart rate variability. | — |
| Ratio of duloxetine exposure in plasma to CSF at steady state. | — |
| Relationship between DHPG and NE concentrations and duloxetine exposure in CSF and plasma. | — |
Countries
United States
Outcome results
None listed