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

Lilly

Status and phase: Completed; Phase 3

Conditions: Depressive Disorder, Major

Treatments: Drug: Duloxetine Hydrochloride; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191919

8605

F1J-BI-HMDH

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind