Depressive Disorder, Major
Conditions
Brief summary
To determine the efficacy of Duloxetine vs. placebo on pain as determined by change in the Brief Pain Inventory (BPI) from baseline over 8 weeks of treatment
Interventions
DRUGDuloxetine Hydrochloride
DRUGPlacebo
Sponsors
Boehringer Ingelheim
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
* Major Depressive Disorder according to DSM-IV criteria with at least one previous depressive episode in the patient's medical history * Painful physical symptoms as measured by the Brief Pain Inventory-Short Form
Exclusion criteria
* Any anxiety disorder as a primary diagnosis within the past 6 months (including panic disorder, OCD, PTSD, generalized anxiety disorder and social phobia) * Any diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare efficacy of Duloxetine versus placebo on somatic complaints of pain in patients meeting criteria for major depressive disorder. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measure Efficacy by the following: MADRS total score, time to sustained clinical response for painful physical symptoms, time to sustained clinical response for overall depression symptoms, SCL-90R scale, PGI-I, CGI-S, CGI-I and BPI-SF. | — |
| Measure safety by the following: adverse events, withdrawals due to AE, vital signs, weight and laboratory values. | — |
Countries
Belgium, Czechia, Finland, France, Germany, Slovakia
Outcome results
None listed