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Mirtazapine Orally Disintegrating Tablet Versus Sertraline: A Prospective Onset of Action Study

Behnke, Kirsten MD*; Søgaard, Jesper MD; Martin, Stephen MD; Bäuml, Josef MD§; Ravindran, Arun V. MD, PhD, FRCP(C); Ågren, Hans MD, PhD; Vester-Blokland, Estelle D. MD#

Journal of Clinical Psychopharmacology: August 2003 - Volume 23 - Issue 4 - p 358-364
doi: 10.1097/
Original Contributions

This multinational, randomized, double-blind study was specifically designed to prospectively compare the onset of antidepressant efficacy of mirtazapine orally disintegrating tablets and sertraline at dosages commonly used in clinical practice. A total of 345 patients with major depressive episode (DSM-IV) received mirtazapine (30–45 mg/d) or sertraline (50–150 mg/d) for 8 weeks. Mirtazapine was administered in the newly developed fast dissolving, orally disintegrating tablet formulation. Assessments were performed at baseline and on days 4, 7, 10, 14, 28, 42, and 56. The primary efficacy variable (mean absolute change from baseline in the Hamilton Depression Rating Scale [HAMD] total score [17 items]) showed that mirtazapine was significantly (P < 0.05) more effective than sertraline at all assessments during the first 2 weeks of the study. After this time, HAMD total scores were similar in both groups. These findings were supported by analysis of the HAMD response rate (ie, ≥50% reduction in HAMD total score from baseline), HAMD remission rate (HAMD total score of ≤7), and the Montgomery-Åsberg Depression Rating Scale (MADRS). Both treatments were well tolerated. In addition, mirtazapine had a greater effect than sertraline on sexual functioning. In conclusion, this first prospective onset of action study using the orally disintegrating tablet indicates that mirtazapine has a faster onset of therapeutic effect than sertraline. The orally disintegrating tablet formulation of mirtazapine used in this study is known to enhance the convenience and compliance by the patient.

*Falkoner Allé, Frederiksberg, The Netherlands;

†Hervigsgade, Kalundborg, The Netherlands;

‡Cherry Knowle Hospital, Ryhope, Sunderland, The Netherlands;

§TU Psychiatric Clinic, Munich, Germany;

∥Institute of Mental Health Research, University of Ottawa, Canada;

¶Karolinska Institute, Huddinge/Stockholm, Sweden;

#Organon International, Roseland, NJ.

Received August 23, 2002; accepted after revision April 20, 2003.

Address correspondence and reprint requests to Estelle D. Vester-Blokland, MD, Organon International, 56 Livingstone Avenue, Roseland, New Jersey, 07068 USA. E-mail:

© 2003 Lippincott Williams & Wilkins, Inc.