Overview

A Randomized Double Blind Study Evaluating Duloxetine in Outpatients With MDD and Pain

Status:
Completed
Trial end date:
2006-05-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Collaborator:
Boehringer Ingelheim
Treatments:
Duloxetine Hydrochloride
Criteria
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