Duloxetine versus placebo in the treatment of major depressive disorder and associated painful physical symptoms: a replication study

• Published in: Current medical research and opinion 2011-10, Vol.27 (10), p.1859-1867
• Main Authors: Gaynor, Paula J., Gopal, Murali, Zheng, Wei, Martinez, James M., Robinson, Michael J., Hann, Danette, Marangell, Lauren B.
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Antidepressive Agents - administration & dosage; Antidepressive Agents - adverse effects; Depressive Disorder, Major - complications; Depressive Disorder, Major - drug therapy; Double-Blind Method; Duloxetine Hydrochloride; Humans; Male; Middle Aged; Pain - complications; Pain - drug therapy; Puerto Rico; Remission Induction; Thiophenes - administration & dosage; Thiophenes - adverse effects; Time Factors; United States
• ISSN: 0300-7995; 1473-4877
• DOI: 10.1185/03007995.2011.609540

Abstract Objective: Painful physical symptoms are common in patients with major depressive disorder (MDD) and can negatively affect patient outcomes. Duloxetine has demonstrated efficacy in treating MDD and other certain painful conditions; this study specifically evaluated patients with both MDD and MDD-associated pain. Methods: This randomized, double-blind clinical trial enrolled adult outpatients with MDD (DSM-IV-TR criteria; Montgomery-Åsberg Depression Rating Scale [MADRS] total score 20) and at least moderate pain (Brief Pain Inventory, Short Form [BPI] average pain rating 3). Patients received placebo (N = 266) or duloxetine (N = 261) 60 mg once daily (QD) (after starting dose of 30 mg QD for 1 week). This study replicated another study evaluating MDD and MDD-associated pain. Clinical trial registration: Clinicaltrials.gov (NCT01070329). Main outcome measures: Co-primary outcomes were the MADRS total score (change from baseline at 8 week endpoint) and BPI average pain rating (overall main effect over 8 weeks of treatment). The Sheehan Disability Scale (SDS) global functional impairment score at week 8 assessed functioning as a secondary outcome. Changes were analyzed using mixed-effects model repeated measures (MMRM), and the MADRS remission rate (total score 12 at 8-week endpoint) was analyzed using the Cochran-Mantel-Haenszel test. Results: Both co-primary objectives and the first two gated secondary objectives were achieved: compared with placebo, duloxetine significantly improved the mean MADRS total score, BPI average pain rating, SDS global functional impairment score, and remission of depression at 8-week endpoint (all p