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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00191919
• Date of registration: 12/09/2005
• Prospective Registration: No
• Primary sponsor: Eli Lilly and Company
• Public title: A Randomized Double Blind Study Evaluating Duloxetine in Outpatients With MDD and Pain
• Scientific 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
• Date of first enrolment: May 2005
• Target sample size: 310
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00191919
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Belgium, Czech Republic, Finland, France, Germany, Slovakia

Contacts

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

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Depressive Disorder, Major

Intervention(s)

Drug: Placebo

Drug: Duloxetine Hydrochloride

Primary Outcome(s)

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

Secondary Outcome(s)

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

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.

Secondary ID(s)

F1J-BI-HMDH

8605

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Boehringer Ingelheim