Depression
Conditions
Brief summary
How duloxetine compares to a medication currently available for the treatment of patients diagnosed with depression
Interventions
DRUGDuloxetine Hydrochloride
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 years of age * Must be diagnosed with depression * Must sign informed consent * Women who can become pregnant must be using birth control
Exclusion criteria
* Previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder * History of substance abuse or dependence in the last year * Patients who are suicidal * Frequent or severe allergic reactions with multiple medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The linear measure of global benefit-risk assessment. Benefit defined as remission at endpoint (HAMD 17 total score less than or equal to 7), a virtually symptom-free state. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impressions of Severity scale to record severity of illness at the time of assessment. | — |
| Patient's Global Impressions of Improvement scale measures improvement of the patient's symptoms. | — |
| HAMD17 Response Rates defined as greater than or equal to 50% reduction in HAMD17 total score from baseline to endpoint. | — |
| Hamilton Anxiety Rating Scale measures the presence and severity of anxiety. | — |
| HAMD17 Remission Rates defined as HAMD17 total score of less than or equal to 7 at endpoint. | — |
| HAMD17 Subscales evaluate severity of psychic and somatic manifestations of anxiety as well as agitation and evaluate dysfunction in mood, work, and sexual activity, as well as overall motor retardation and evaluate initial, middle, and late insomnia. | — |
| HAMD17 Time-to-First Response defined as the visit where a sustained greater than or equal to 30% reduction in the Maier subscale of the HAMD17. | — |
Countries
France
Outcome results
None listed