To characterize the co-existence of multiple pain-related complaints in patients enrolled in a series of pharmaceutical company drug trials for the treatment of Major Depressive Disorder (MDD).
Pooled ‘blinded' data from 2191 patients enrolled in randomized, multicenter, double-blind placebo-controlled studies for the treatment of MDD were analyzed. Painful symptoms were assessed using the seven pain symptoms subset of the Somatic Symptoms Inventory: ‘Headache,' ‘Pain in lower back,' ‘Neck pain,' ‘Pain in joints,' ‘Soreness in muscles,' ‘Pain in heart or chest,' and ‘Pain or cramps in abdomen.' The 17-item Hamilton Depression Rating Scale (HAMD) was used to assess severity of depression.
Of those meeting the study entry criteria (total HAMD score ≥15), 25% reported no pain complaints and 18% reported 1 pain compliant; the majority (57%) of patients reported the co-existence of multiple pain-related complaints, with 14%, 12%, 11%, 11%, 7%, and 3% of patients reporting 2, 3, 4, 5, 6 and 7 different pain symptoms, respectively. The number of pain-related symptoms experienced was moderately related to severity of depression (r = 0.35), with the most common pain symptom combinations being among headaches, lower back pain, neck pain, pain in joints, and soreness in muscles.
This study supports pain as a component feature of MDD. The number of comorbid pain-related complaints, which generally increased as a function of depressive severity, should be considered in the diagnosis of depression, planning of treatment strategies, and measurement of treatment outcome.
MDD = Major Depressive Disorder; SSI = Somatic Symptoms Inventory; HAMD = Hamilton Depression Rating Scale; DSM-IV-TR = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision; ICD-10 = International Classification of Diseases, 10th Revision.
From the Ontario Cancer Biomarker Network, Toronto, Ontario, Canada, (A.L.V., T.L.S., K.R.E.); International Society for CNS Drug Development, San Diego, California (A.L.V., A.H.K.); Quintiles CNS Therapeutics (A.H.K.); and Department of Psychiatry, University of California, San Diego, California (A.H.K.).
Address correspondence and reprint requests to Anthony L. Vaccarino, PhD, Ontario Cancer Biomarker Network, MaRS Centre, South Tower, 101 College Street, Suite 200, Toronto, Ontario, Canada M5G 1L7. E-mail: firstname.lastname@example.org
Received for publication March 6, 2008; revision received July 27, 2008.
Supported by the International Society for CNS Drug Development. The data set used in the analysis was provided by Eli Lilly.
Presented in part at the Annual American College of Neuropsychopharmacology (ACNP) meeting in Boca Raton, Florida, December, 2007.