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Completed

NCT Number: NCT00191919

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

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

Completed

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Key information

Conditions

Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

duloxetine hydrochloride

Drug

Placebo

Drug

Primary outcomes

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

Secondary outcomes

  1. 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.

  2. Measure safety by the following: adverse events, withdrawals due to AE, vital signs, weight and laboratory values.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Boehringer Ingelheim

Registry information

Official study title

A Ten-Week, Randomized, Double-Blind Study Evaluating the Efficacy of Duloxetine 60mg Once Daily Versus Placebo in Outpatients With Major Depressive Disorder and Pain

Important dates

Study start
2005
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
Jan 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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