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Escitalopram (10–20 mg/day) is effective and well tolerated in a placebo‐controlled study in depression in primary care

Lepola, Ulla M.; Loft, Henrik; Reines, Elin Heldbo

International Clinical Psychopharmacology: July 2003 - Volume 18 - Issue 4 - p 211–217
Original Articles

Escitalopram was compared to placebo in moderately to severely depressed patients in primary care with citalopram as the active reference. Patients were randomized to receive flexible doses of 10–20 mg/day escitalopram (n=155), 20–40 mg/day citalopram (n=160), or placebo (n=154) over an 8‐week double‐blind period. The primary efficacy parameter was the change from baseline to last assessment in the Montgomery–Asberg Depression Rating Scale total score. Escitalopram produced a statistically significant therapeutic difference of 2.9 points (P=0.002) compared to placebo, and escitalopram was consistently and statistically significantly more efficacious than placebo from week 1 onwards. Analysis of Clinical Global Impression–Severity and Clinical Global Impression–Improvement confirmed the primary efficacy results. By week 8, significantly more patients had responded to treatment with escitalopram than with citalopram (P=0.021) or placebo (P=0.009). Escitalopram was as well tolerated as citalopram and had a similar adverse event profile. Both escitalopram‐ and citalopram‐treated patients had placebo‐level adverse event withdrawal rates (3% and 4%, respectively). This study demonstrates the consistent antidepressant efficacy and excellent tolerability of escitalopram 10–20 mg/day in primary care patients with major depressive disorder.

a Kuopion Psykiatripalvelu OY Psychiatric Research, Clinic of Kuopio, Kuopio, Finland

b Department of Psychiatry, Oulu and Helsinki University, Finland

c H. Lundbeck A/S, International Clinical Research, Copenhagen Valby, Denmark

Correspondence and requests for reprints to Henrik Loft, H. Lundbeck A/S, International Clinical Research, 9 Ottiliavej, DK‐2500 Copenhagen Valby, Denmark.

Tel: +45 36 43 23 04; fax: +45 36 43 82 96; e‐mail: hlo@lundbeck.com

Received 4 February 2003 Accepted 8 April 2003

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