Depression
Conditions
Brief summary
The purposes of this study are to determine: * The safety of duloxetine and any side effects that might be associated with it. * How duloxetine compares to escitalopram and placebo (an inactive ingredient)
Detailed description
duloxetine 60mg - 120mg, escitalopram 10mg - 20mg, and placebo, 8-month,
Interventions
DRUGduloxetine
DRUGescitalopram
DRUGplacebo
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be at least 18 of age * Must meet the criteria for major depressive disorder * You must be able to visit the doctor's office about once a week for 2 to 3 months. After that, you will need to visit the doctor's office once a month for about 6 months * You must be able to take the study drug as prescribed (6 capsules per day taken once-daily)
Exclusion criteria
* You are a woman and are pregnant or breastfeeding. * You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder. * You have a history of alcohol or drug dependence within the past 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the onset of antidepressant efficacy for duloxetine 60 mg once-daily compared with escitalopram 10 mg once-daily. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the efficacy of duloxetine 60 mg once-daily versus escitalopram 10 mg once-daily and placebo during acute therapy | — |
| To compare the efficacy of duloxetine 60-120 mg once-daily versus escitalopram 10-20 mg once-daily and placebo for up to 8 months of therapy | — |
| To compare incidence of sexual dysfunction (defined by Changes in Sexual Functioning Questionnaire (CSFQ)), during acute therapy for patients treated with duloxetine 60 mg once-daily versus escitalopram 10 mg once-daily & placebo. | — |
| To compare sexual dysfunction during up to 8 months of treatment with duloxetine 60-120 mg once-daily versus escitalopram 10 to 20 mg once-daily and placebo | — |
| To compare impact of duloxetine 60 mg once-daily versus escitalopram 10 mg once-daily & placebo during acute therapy & during 8 months of therapy on quality of life, functional/health outcomes, & patient satisfaction with study drug | — |
| To evaluate the safety and tolerability of duloxetine 60-120 mg once-daily vs. escitalopram 10-20 mg once-daily and placebo for up to 8 months of therapy | — |
| To compare impact of duloxetine 60-120 mg once-daily versus escitalopram 10-20 mg once-daily and placebo during acute and extended therapy on resource utilization (% patients using more,less or equal number of health care providers and services) | — |
| To evaluate safety and tolerability of duloxetine 60 mg once-daily vs. escitalopram 10 mg once-daily and placebo during acute therapy | — |
| To compare percentage of patients taking duloxetine 60 mg once-daily versus escitalopram 10 mg once-daily and placebo requiring a dose escalation due to less than satisfactory initial response (defined by IRB supplement or investigator request) | — |
| To compare efficacy of duloxetine versus escitalopram in the placebo non-responders who enter the rescue phase | — |
| To compare impact of duloxetine 60-120 mg once-daily versus escitalopram 10 to 20 mg once-daily and placebo for up to 8 months of therapy on quality of life, functional/health outcomes, & patient satisfaction with study drug | — |
Countries
United States
Outcome results
None listed