A Study of Duloxetine in Major Depressive Disorder (MDD) and Associated Painful Symptoms

NCT01000805 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 528

Last updated 2012-01-13

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for 8 weeks to patients diagnosed with major depressive disorder, who also report associated painful physical symptoms, is better than placebo when treating depression and its associated painful symptoms.

Conditions

Interventions

DRUG

Duloxetine

Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.

DRUG

Placebo

Participants received placebo QD, po for 8 weeks.

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT-5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States
  • France
  • Germany
  • Puerto Rico
  • Romania
  • Sweden

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01000805 on ClinicalTrials.gov