Predictors of response to treatment of acute bipolar manic episodes with divalproex sodium or placebo in 2 randomized, controlled, parallel-group trials.
Identification and control of factors that are associated with placebo and drug response in acute mania may influence the design and analysis of future trials in this condition. We analyzed pooled data from 2 multicenter, placebo-controlled, randomized trials of divalproex sodium for the treatment of acute manic episodes, using linear and logistic regression to search for common and treatment-specific predictors of response. In both treatment groups, patients with greater numbers of prior hospitalizations, more severe baseline symptoms, or younger age at onset of illness were found to be significantly less likely to respond. The effect sizes associated with these factors were of comparable magnitude to the effect size associated with divalproex treatment. Stratification on the basis of these prognostic factors may improve the power of future trials for the treatment of acute mania and may help explain patient response to treatment.
Welge
Jeffrey A
JA
Division of Clinical Neuroscience, Psychopharmacology Research Program, Department of Psychiatry, University of Cincinnati College of Medicine, Cincinnati Veterans Affairs Medical Center, Cincinnati, OH, USA. welgeja@uc.edu
Keck
Paul E
PE
Meinhold
Jane M
JM
D000328:Adult; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000523:psychology; D016009:Chi-Square Distribution; D005260:Female; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data; D011237:Predictive Value of Tests; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D016896:Treatment Outcome; D014635:Valproic Acid / Q000627:therapeutic use*
D014635:Valproic Acid