Major Depressive Disorder
Conditions
Brief summary
A multicentre, randomised, open label study of out-patients with major depression who have failed to respond adequately to antidepressant treatment for their current episode of depression. The study compares outcomes associated with two methods of switching from current antidepressant to duloxetine
Interventions
DRUGDuloxetine
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female outpatients of at least 18 years of age, who meet criteria for Major Depressive Disorder (MDD) * Currently non- or only partially-responsive to an SSRI antidepressant after at least 5 weeks of treatment
Exclusion criteria
include: * Current primary Axis I disorder other than MDD * Previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders * Patients judged to be at serious suicidal risk. * Serious medical illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To test the hypothesis that the efficacy associated with direct switch from SSRI to duloxetine is non-inferior to start-taper switch | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the efficacy, health outcomes, safety and tolerability associated with the above two switching methods, as measured by HAMD17, CGI-S, PGI-I, SF-36, spontaneously reported adverse events , vital signs and other measures. | — |
Countries
France, Ireland, Spain, United Kingdom
Outcome results
None listed