title: The effect of duloxetine treatment on cognition in patients with fibromyalgia.
abstract: OBJECTIVE
  To determine the effect of duloxetine treatment on cognition in patients with fibromyalgia.
  
  
  METHODS
  Cognitive testing was conducted in a subset of adult patients in a randomized, double-blind, placebo-controlled trial of duloxetine. Patients met the American College of Rheumatology criteria for fibromyalgia and had a score of 4 or higher on the Brief Pain Inventory 24-hour average pain severity item. Patients who consented to cognitive testing were randomized to duloxetine (n = 80) or placebo (n = 76). The primary end point was at Week 12. Speed of processing on tasks requiring visual attention, working memory, and executive function was assessed with a Symbol Digit Substitution Test and Trail-Making Test A and B. Episodic memory was tested using the Verbal Learning and Recall Test. The change from baseline to end point (last-observation-carried-forward analysis) was analyzed by an analysis of covariance model, which included baseline, treatment, investigator, and treatment-by-investigator interaction.
  
  
  RESULTS
  Most of the patients were white (89%) women (92%), ranging in age from 21 to 88 years. Mean scores on the cognitive tests were within 2 SD of published scores for similar-aged participants in the general population, indicating no substantial impairment. Baseline-to-end point changes in cognitive scores did not differ significantly between duloxetine and placebo treatment groups.
  
  
  CONCLUSIONS
  Although scores differed somewhat from norms for age, substantial cognitive impairment was not evident in patients with fibromyalgia as assessed by the Symbol Digit Substitution Test, Trail-Making Test, and Verbal Learning and Recall Test. Overall, duloxetine treatment had neither positive nor negative effects on cognition.
  
  
  BACKGROUND
  Clintrials.gov NCT00673452.
authors: Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA.
authors: Richard
authors: R
authors: Mohs
authors: Philip
authors: P
authors: Mease
authors: Lesley M
authors: LM
authors: Arnold
authors: Fujun
authors: F
authors: Wang
authors: Jonna
authors: J
authors: Ahl
authors: Paula J
authors: PJ
authors: Gaynor
authors: Madelaine M
authors: MM
authors: Wohlreich
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D001288:Attention / Q000187:drug effects; D003072:Cognition Disorders / Q000188:drug therapy* / Q000209:etiology; D000068736:Duloxetine Hydrochloride; D056344:Executive Function / Q000187:drug effects; D005260:Female; D005356:Fibromyalgia / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D008297:Male; D061212:Memory, Episodic; D008570:Memory, Short-Term / Q000187:drug effects; D008875:Middle Aged; D009483:Neuropsychological Tests / Q000706:statistics & numerical data; D010146:Pain / Q000188:drug therapy; D010147:Pain Measurement; D010919:Placebos; D011930:Reaction Time / Q000187:drug effects; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013876:Thiophenes / Q000627:therapeutic use*; D016896:Treatment Outcome; D014706:Verbal Learning / Q000187:drug effects; D055815:Young Adult
chemical_list: D000068736:Duloxetine Hydrochloride; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors; D013876:Thiophenes