ILLNESS CHARACTERISTICS OF PATIENTS IN CLINICAL DRUG STUDIES OF MANIA

Two recent large-scale studies of the effectiveness and safety of diva lproex versus lithium and placebo in the manic phase of bipolar disord er have provided an opportunity to investigate the characteristics of patients enrolled in clinical drug trials of mood stabilizers. Both st udies are randomized, double-blind, parallel-group, multicenter trials ; the first addresses effectiveness in acute mania, and the second add resses effectiveness in prevention of manic episodes. Data on demograp hic, illness severity, and treatment response characteristics were com pared between Study 1 and six other clinical drug trials in acute mani a from the past decade that had data in comparable domains. Although p atients experienced onset of bipolar disorder in their early twenties, the average age of enrollment in the studies was about 40. Approximat ely equal numbers of men and women were enrolled. The patients were se verely ill at the time of enrollment, with mean scores on the Global A ssessment Scale ranging from 29 to 37. Overall, characteristics were r emarkably similar across studies and representative of those reported in epidemiological studies. From Study 2, which is currently in progre ss, characteristics of patients recruited into the trial were determin ed. At least 10 subjects were initially assessed for each subject actu ally enrolled in the trial. The two factors most associated with failu re to move from the open phase of the study to the randomized phase we re administrative problems (principally failure of subjects to adhere to the medication regimen and protocol requirements) and inability, ev en with an open treatment protocol, to achieve adequate recovery from the index manic episode within 3 months.