A Randomized Double Blind Study Evaluating Duloxetine in Outpatients With MDD and Pain
Phase 3
Completed
- Conditions
- Depressive Disorder, Major
- Registration Number
- NCT00191919
- Lead Sponsor
- Eli Lilly and Company
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 310
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Compare efficacy of Duloxetine versus placebo on somatic complaints of pain in patients meeting criteria for major depressive disorder.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇸🇰Rimavaska Sobota, Slovakia