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

Phase 3CompletedNCT00191919

Eli Lilly and Company310 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

310

Conditions

Depressive Disorder, Major

Interventions

Duloxetine HydrochlorideDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (38)

Outcomes

Primary Outcomes

Compare efficacy of Duloxetine versus placebo on somatic complaints of pain in patients meeting criteria for major depressive disorder.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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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.

Antwerpert, Belgium

Asse, Belgium

Assebroek, Belgium

Diest, Belgium

Genk, Belgium

Leuven, Belgium

Ostend, Belgium

Yvoir, Belgium

Prague, Czechia

Espoo, Finland

...and 28 more locations