A double-blind double-dummy study of citalopram comparing infusion versus oral administration

Abstract

Background: This study compares antidepressant efficacy and tolerability of citalopram given either orally or as a slow drop infusion. Methods: Citalopram (40 mg/day) was administered double-blindly as tablets or slow-drop infusion during the first 10 days and then open, orally, up to treatment Day 42. Results: In 60 moderately to severely depressed patients, the Hamilton depression total score (17-items) at baseline was 23.9 and 23.6 in the active infusion ( n=30) and active tablet ( n=30) group, respectively. These scores dropped in both groups to 15.6 and 16.9 on Day 10, and to 10.3 and 10.2 on Day 42. Response rates (Δ Hamilton≥50%) amounted to 33.3% and 17.9% on Day 10, and 66.2% and 63.3% on Day 42, without a relevant group difference in citalopram plasma concentration. Conclusion: Slow-drop infusion with citalopram shows a similar risk/benefit relationship to oral citalopram. The design of this study allowed us to evaluate pharmacological but not psychological factors which may contribute to response to slow-drop infusion.