Lexapro and Zoloft demonstrated comparable efficacy in reducing symptoms of depression and anxiety in patients with major depressive disorder. At week eight of the study, 75 percent of Lexapro-treated patients and 70 percent of Zoloft-treated patients were considered responders, meaning they achieved a 50 percent or better reduction from baseline in their Montgomery-Asberg Depression Rating Scale (MADRS) scores. Mean changes in MADRS scores from baseline to endpoint were 19.1 and 18.4 for the Lexapro and Zoloft groups, respectively. For patients who were severely depressed at baseline (MADRS score 30; N=92), mean changes in MADRS scores from baseline to endpoint were 22.4 and 20.4 for the Lexapro and Zoloft groups, respectively. Patients treated with Lexapro and Zoloft each experienced improvement in anxiety symptoms associated with depression, according to the Hamilton Rating Scale for Depression (HAM-D) Anxiety Subscale total score.

Both Lexapro and Zoloft were well tolerated in the eight-week study. Overall, about 85 percent of patients in each group completed the study. Only two and four percent of patients discontinued due to adverse events with Lexapro and Zoloft, respectively. Adverse events occurring at an incidence of >10 percent with Lexapro or Zoloft, respectively, included ejaculation disorder (23% and 23%), diarrhea (13% and 23%), nausea (17% and 17%), insomnia (14% and 17%), libido decreased (10% and 14%), upper respiratory tract infection (10% and 14%), dry mouth (4% and 14%), headache (13% and 10%), and somnolence (12% and 6%).

Study Methodology

Two hundred twelve patients, 18 to 80 years of age with major depressive disorder (baseline MADRS score 22), participated in the double-blind study. Following a one-week, single-blind, placebo lead-in period, patients were randomized to receive either a fixed dose of 10 mg per day of Lexapro (N=104) or a flexible dose of 50 to 200 mg per day of Zoloft
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Contact: Charles E. Triano
212-224-6714
Forest Laboratories
10-Dec-2003