Major Depressive Disorder
Conditions
Brief summary
To assess the effectiveness of duloxetine administered once daily in patients with Major Depressive Disorder in a practice based setting
Detailed description
To assess physical and emotional symptoms of depressed patients
Interventions
DRUGduloxetine hydrochloride
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meet criteria for major depressive disorder according to the DSM-IV diagnostic criteria * Outpatients at least 18 years of age * Sign the informed consent * All females must test negative for a urine pregnancy test at visit 1. Females of child bearing potential must agree to utilize medically acceptable and reliable means of birth control * Have a level of understanding sufficient to communicate with the investigator and are able to complete all patient self-rated scales in the study
Exclusion criteria
* Are investigator site personnel directly affiliated with the study or immediate family * Are employed by Eli Lilly and Company * Have received treatment within the last 30 days or are currently enrolled in a study with a drug that has not received regulatory approval for any indication at time of study entry * Current substance dependence, excluding nicotine and caffeine * Treatment with a monoamine oxidase inhibitor within 14 days prior to visit 1 or potential need to use an MAOI within 5 days after discontinuation of study drug * Acute liver injury or severe (Child-Pugh Class C) cirrhosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Global Impression of Severity | — |
| Somatic Symptom Inventory | — |
| Depressive Symptomatology-Self Report | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Global Impression of Improvement | — |
| Mood and Physical Symptoms in Depression | — |
| Quality of Life Enjoyment Satisfaction Questionnaire-Short form | — |
Countries
United States
Outcome results
None listed