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Mirtazapine: efficacy and tolerability in comparison with fluoxetine in patients with moderate to severe major depressive disorder. Mirtazapine-Fluoxetine Study Group.
J Clin Psychiatry. 1998 Jun; 59(6):306-12.JC

Abstract

OBJECTIVE

To compare the efficacy and tolerability of mirtazapine and fluoxetine in depressed inpatients and outpatients.

METHOD

Patients with a major depressive episode (DSM-III-R), a baseline score of > or=21 on the 17-item Hamilton Rating Scale for Depression (HAM-D), and > or=2 on HAM-D Item 1 (depressed mood) were randomly assigned to a 6-week treatment with either mirtazapine (N=66, 15-60 mg/day) or fluoxetine (N=67, 20-40 mg/day). The upper limit of the mirtazapine dose range was above the dose range approved in the United States (15-45 mg/day). Efficacy was evaluated by the HAM-D, Clinical Global Impressions, the Visual Analogue Mood Rating Scale (VAMRS), and the Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ). The efficacy analyses were performed on the intent-to-treat group using the last-observation-carried-forward method.

RESULTS

Mean total 17-item HAM-D scores at baseline were 26.0 for the mirtazapine- and 26.1 for the fluoxetine-treated group. The decrease from baseline on the HAM-D was larger in the mirtazapine than in the fluoxetine group throughout the treatment period, reaching statistical significance at days 21 and 28. At assessments from day 21 and onward, the absolute difference between the 2 study groups favoring mirtazapine ranged from 3.7 to 4.2 points, the magnitude of difference usually seen between an efficacious antidepressant drug and placebo. Mean dosages at weeks 1-4 were 36.5 mg/day for mirtazapine and 19.6 mg/day for fluoxetine; the respective dosages at weeks 5-6 were 56.3 mg and 35.8 mg. Similar numbers of patients dropped out due to adverse events; tolerability profiles were comparable except for changes in body weight from baseline which were statistically significantly more pronounced in the mirtazapine group compared to the fluoxetine group.

CONCLUSION

We found that mirtazapine was as well tolerated as fluoxetine and significantly more effective after 3 and 4 weeks of therapy.

Authors+Show Affiliations

The Royal Masonic Hospital, London, United Kingdom.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

9671343

Citation

Wheatley, D P., et al. "Mirtazapine: Efficacy and Tolerability in Comparison With Fluoxetine in Patients With Moderate to Severe Major Depressive Disorder. Mirtazapine-Fluoxetine Study Group." The Journal of Clinical Psychiatry, vol. 59, no. 6, 1998, pp. 306-12.
Wheatley DP, van Moffaert M, Timmerman L, et al. Mirtazapine: efficacy and tolerability in comparison with fluoxetine in patients with moderate to severe major depressive disorder. Mirtazapine-Fluoxetine Study Group. J Clin Psychiatry. 1998;59(6):306-12.
Wheatley, D. P., van Moffaert, M., Timmerman, L., & Kremer, C. M. (1998). Mirtazapine: efficacy and tolerability in comparison with fluoxetine in patients with moderate to severe major depressive disorder. Mirtazapine-Fluoxetine Study Group. The Journal of Clinical Psychiatry, 59(6), 306-12.
Wheatley DP, et al. Mirtazapine: Efficacy and Tolerability in Comparison With Fluoxetine in Patients With Moderate to Severe Major Depressive Disorder. Mirtazapine-Fluoxetine Study Group. J Clin Psychiatry. 1998;59(6):306-12. PubMed PMID: 9671343.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Mirtazapine: efficacy and tolerability in comparison with fluoxetine in patients with moderate to severe major depressive disorder. Mirtazapine-Fluoxetine Study Group. AU - Wheatley,D P, AU - van Moffaert,M, AU - Timmerman,L, AU - Kremer,C M, PY - 1998/7/22/pubmed PY - 1998/7/22/medline PY - 1998/7/22/entrez SP - 306 EP - 12 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 59 IS - 6 N2 - OBJECTIVE: To compare the efficacy and tolerability of mirtazapine and fluoxetine in depressed inpatients and outpatients. METHOD: Patients with a major depressive episode (DSM-III-R), a baseline score of > or=21 on the 17-item Hamilton Rating Scale for Depression (HAM-D), and > or=2 on HAM-D Item 1 (depressed mood) were randomly assigned to a 6-week treatment with either mirtazapine (N=66, 15-60 mg/day) or fluoxetine (N=67, 20-40 mg/day). The upper limit of the mirtazapine dose range was above the dose range approved in the United States (15-45 mg/day). Efficacy was evaluated by the HAM-D, Clinical Global Impressions, the Visual Analogue Mood Rating Scale (VAMRS), and the Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ). The efficacy analyses were performed on the intent-to-treat group using the last-observation-carried-forward method. RESULTS: Mean total 17-item HAM-D scores at baseline were 26.0 for the mirtazapine- and 26.1 for the fluoxetine-treated group. The decrease from baseline on the HAM-D was larger in the mirtazapine than in the fluoxetine group throughout the treatment period, reaching statistical significance at days 21 and 28. At assessments from day 21 and onward, the absolute difference between the 2 study groups favoring mirtazapine ranged from 3.7 to 4.2 points, the magnitude of difference usually seen between an efficacious antidepressant drug and placebo. Mean dosages at weeks 1-4 were 36.5 mg/day for mirtazapine and 19.6 mg/day for fluoxetine; the respective dosages at weeks 5-6 were 56.3 mg and 35.8 mg. Similar numbers of patients dropped out due to adverse events; tolerability profiles were comparable except for changes in body weight from baseline which were statistically significantly more pronounced in the mirtazapine group compared to the fluoxetine group. CONCLUSION: We found that mirtazapine was as well tolerated as fluoxetine and significantly more effective after 3 and 4 weeks of therapy. SN - 0160-6689 UR - https://www.unboundmedicine.com/medline/citation/9671343/Mirtazapine:_efficacy_and_tolerability_in_comparison_with_fluoxetine_in_patients_with_moderate_to_severe_major_depressive_disorder__Mirtazapine_Fluoxetine_Study_Group_ L2 - http://www.psychiatrist.com/jcp/article/pages/1998/v59n06/v59n0606.aspx DB - PRIME DP - Unbound Medicine ER -