Lexapro Clinical Trials and Studies

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Lexapro Clinical Trials and Studies

The efficacy of Lexapro as a treatment for major depressive disorder has been established, in part, on the basis of extrapolation from the established effectiveness of racemic citalopram, of which escitalopram is the active isomer. In addition, the efficacy of escitalopram was shown in an 8-week fixed dose study that compared 10 mg/day Lexapro and 20 mg/day Lexapro to placebo and 40 mg/day citalopram, in outpatients between 18 and 65 years of age who met DSM-IV criteria for major depressive disorder. The 10 mg/day and 20 mg/day Lexapro treatment groups showed significantly greater mean improvement compared to placebo on the Montgomery Asberg Depression Rating Scale (MADRS). The 10 mg and 20 mg Lexapro groups were similar in mean improvement on the MADRS score.

Analyses of the relationship between treatment outcome and age, gender, and race did not suggest any differential responsiveness on the basis of these patient characteristics. Longer-term efficacy of escitalopram in major depressive disorder has not been systematically evaluated; however, longer-term efficacy of racemic citalopram in this population has been established. In two longer-term studies, patients meeting DSM-III-R criteria for major depressive disorder who had responded (MADRS < 12) during an initial 6 or 8 weeks of acute treatment on racemic citalopram (fixed doses of 20 or 40 mg/day in one study and flexible doses of 20-60 mg/day in the second study) were randomized to continuation of racemic citalopram or to placebo, for up to 6 months of observation for relapse. In both studies, patients receiving continued racemic citalopram treatment experienced significantly lower relapse rates (MADRS 22 in the fixed dose study; MADRS 25 in the flexible dose study) over the subsequent 6 months compared to those receiving placebo. In the fixed dose study, the decreased rate of depression relapse was similar in patients receiving 20 or 40 mg/day of racemic citalopram.

In a third longer-term trial, patients meeting DSM-IV criteria for major depressive disorder, recurrent type, who had responded (MADRS total score £ 11) and continued to be improved (MADRS total score never exceeded 22 and returned to £ 11 before randomization) during an initial 22-25 weeks of treatment on racemic citalopram (20-60 mg/day) were randomized to continuation of their same racemic citalopram dose or to placebo. The follow-up period to observe patients for relapse, defined either in terms of increases in the MADRS (MADRS total score > 22) or a judgement by an independent review board that discontinuation was due to relapse, was for up to 72 weeks. Patients receiving continued racemic citalopram treatment experienced significantly lower relapse rates over the subsequent 72 weeks compared to those receiving placebo.

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