Depressive Symptoms
Conditions
Brief summary
This double-blind placebo-controlled trial is designed to test and to compare the cardiovascular profile of paroxetine controlled release (CR) with duloxetine in outpatients with depressive symptoms.
Detailed description
This double-blind placebo-controlled study will test the hypothesis that greater reduction in heart rate variability will be associated with duloxetine than paroxetine in outpatients with major depressive disorder. We will also examine the relationship between changes in heart rate variability to the magnitude of serotonin and norepinephrine transporter occupancy produced by each drug.
Interventions
DRUGparoxetine versus duloxetine
Sponsors
GlaxoSmithKline
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Depressive symptoms * Ages 20-60 * In good medical health and not pregnant
Exclusion criteria
* Bipolar disorder * Schizophrenia or other psychotic disorder * Alcohol or other substance abuse within the last 3 months * Cognitive impairment * History of attempted suicide in the past 2 months and who score 4 or more on the suicide item of the MADRS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R-R interval change with deep breathing | — |
| Respiratory sinus arrhythmia | — |
Secondary
| Measure | Time frame |
|---|---|
| Spielberger State-Trait Anxiety Inventory | — |
| Connor-Davidson Resilience Scale | — |
| Montgomery-Asberg Depression Rating Scale (MADRS) | — |
| Serotonin receptor occupancy | — |
| Norepinephrine receptor occupancy | — |
| Hospital Anxiety and Depression Scale | — |
Countries
United States
Outcome results
None listed