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Patient-Assessed Versus Physician-Assessed Disease Severity and Outcome in Patients With Nonspecific Pain Associated With Major Depressive Disorder
Objectives: This post hoc analysis compared how patients and physicians estimate disease severity and global improvement during 8 weeks of treatment for major depressive disorder (MDD) with associated nonspecific pain. In addition, predictors of pain and depression were identified.
Method: Data were derived from a double-blind, placebo-controlled, multicenter, European study (conducted from May 2005 to May 2006) in adult outpatients with MDD (DSM-IV criteria) and moderate pain not attributable to a diagnosed organic pain syndrome (Brief Pain Inventory-Short Form [BPI-SF] average pain score ≥3). Patients were randomly assigned to duloxetine 60 mg/day or placebo and treated for 8 weeks. Physicians were asked to rate severity of depression by using the Montgomery-Asberg Depression Rating Scale (MADRS) and the Clinical Global Impressions-Severity of Illness (CGI-S) and CGI-Improvement (CGI-I) scales. Patients were asked to assess pain using the BPI-SF, psychological symptomatology (9 domains including depression) with the Symptom Checklist-90-Revised (SCL-90-R), and overall improvement with the Patient Global Impression of Improvement (PGI-I). Multivariate linear regressions were performed as post hoc analyses to identify predictors of disease assessment at baseline and at the end of the study using a last-observation-carried-forward approach.
Results: All SCL-90-R domains improved during the 8 weeks of treatment. At baseline, the MADRS was associated only with the SCL-90-R obsessive-compulsive score, while the SCL-90-R depression score was associated with the BPI-SF average pain score and with many SCL-90-R subscores. The global impression of improvement was rated higher by the physicians than by the patients. At the end of the study, CGI-I was significantly associated with a decrease in depression severity (MADRS; p <.0001), younger age (p =.0005), and a decrease of the SCL-90-R interpersonal sensitivity score (p =.0359), but not with BPI-SF average pain. In contrast, patient-rated PGI-I was significantly associated with the SCL-90-R depressive domain (p <.0001), BPI-SF average pain (p =.0003), and the SCL-90-R anxiety domain (p =.0041) scores.
Conclusions: In patients with MDD associated with at least moderate nonspecific pain, physicians consider mainly the change in depressive symptoms as measured by MADRS in their CGI-I ratings, while patients also consider pain, depression, and anxiety in their PGI-I ratings. When treating depression and assessing treatment outcome, a broad spectrum of symptoms needs to be monitored.
(Prim Care Companion J Clin Psychiatry 2009;11(1):8-15. doi:10.4088/PCC.08m00670)
Received May 15, 2008; accepted July 28, 2008. From the University Psychiatric Center, Catholic University of Leuven, Campus Gasthuisberg, Leuven, Belgium (Dr. Demyttenaere); Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Ind. (Dr. Desaiah); Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Conn. (Dr. Petit); Boehringer Ingelheim Pharma GmbH & Co., KG, Biberach, Germany (Dr. Croenlein); and Boehringer Ingelheim GmbH, Ingelheim, Germany (Dr. Brecht).
This study was sponsored by Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany, and Eli Lilly and Co., Indianapolis, Ind. The authors accept full responsibility for the conduct of this study, had full access to all data from this study, and participated in the decision to publish the data.
Presented at the 20th annual congress of the European College of Neuropsychopharmacology; Oct. 13-17, 2007; Vienna, Austria.
The authors wish to thank all the investigators and patients for their role in the conduct of this study.
Dr. Demyttenaere has served on the advisory boards of and received honoraria for services from Boehringer Ingelheim and Eli Lilly. Dr. Desaiah is an employee and stock shareholder of Eli Lilly. Drs. Petit, Croenlein, and Brecht are employees of Boehringer Ingelheim.
Corresponding author and reprints: Koen Demyttenaere, M.D., Ph.D., University Psychiatric Center-Campus Gasthuisberg, Herestraat 49, 3000 Leuven, Belgium (e-mail: Koen.Demyttenaere@med.kuleuven.be).