Depression
Conditions
Brief summary
How duloxetine compares to a medication currently available for the treatment of depression in the treatment of patients with major depressive disorder. The safety of duloxetine and any side effects that might be associated with it.
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
Exclusion criteria
* women who can become pregnant must be using birth control * 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 |
|---|---|
| Linear measure of global benefit-risk assessment. Benefit is defined as remission at endpoint (HMAD17 total score less than or equal to 7, a virtually symptom-free state. | — |
Secondary
| Measure | Time frame |
|---|---|
| HAMD17 Time to First Response: Time to first response is defined as the visit where a sustained greater than or equal to 30% reduction in the Maier subscale of the HAMD17. | — |
| HAMD17 Remission Rates: Remission is defined as a HAMD17 total score of less than or equal to 7 at endpoint. | — |
| Hamilton Anxiety Rating Scale (HAMA) that measures the presence and severity of anxiety. The 14-item version of this scale will be used to assess the severity of anxiety and its improvement during the course of therapy. | — |
| HAMD17 Response Rates: Response is defined as a greater or equal to 50% reduction in HAMD17 total score from baseline to endpoint. | — |
| Patient's Global Impressions of Improvement (PGI Improvement) Scale is a patient-rated instrument that measures the improvement of the patient's symptoms. | — |
| HAMD17 Subscales to evaluate severity of psychic and somatic manifestations of anxiety, as well as agitation; evaluate dysfunction in mood, work, and sexual activity, as well as overall motor retardation; evaluate initial, middle and late insomnia. | — |
| Clinical Global Impressions of Severity (CGI-Severity) Scale to record the severity of illness at the time of assessment. | — |
Countries
Canada
Outcome results
None listed