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Tolerability of mirtazapine vs SSRIs in short term treatment of major depression
S229
PI Affective disorders and antidepressants
present in the MADRS, HAM-A and CC&Severity of Illness and Quality of life scores. Both drugs were well tolerated. Sweating and nausea were significantly more frequent in the citalopram group and increased appetite and weight increase in the mirtazapine group. Conclusions: Mirtazapine and citalopram were equally effective in reducing symptoms of depression and anxiety, and well tolerated. However, mirtazapine was significantly more effective than citalopram after 2 weeks of treatment on MADRS, HAM-A and CGI-Severity of Illness and Quality of life scales. This finding, consistently present at all major efficacy variables, suggests potentially faster onset of action of mirtazapine.
17-HAMD scores were 27 at baseline, and further decreased to a value of 21 at day 7, 14 at day 21 and 6.5 at day 84. The most frequently reported adverse events were somnolence in 17% and weight gain in 2.3% of patients. Conclusion: The results of this open-label study are in line with the results of randomized, double-blind studies of mirtazpaine. They confirm rapid and sustained antidepressant efficacy of mirtazapine combined with a favorable tolerability profile.
Ip.1.0651
Mirtaxapine
and ECT as combination
therapy
B. Soderstrom. Psychiatric Clinic, Varberg Hospital, Varberg, Sweden (p.1.0631
Tolerability of mirtazapine vs SSRls in short term treatment of major depression
C.M.E. Kremer’, J.T.H. Helsdingen, J.A. Schutte, E. Vester. ‘Organon Inc., Mount Pleasant Ave. 375, West Orange, NJ 07052, USA Aim: To compare overall tolerability of mirtazapine versus SSRIs used
in short-term treatment of major depression. Method: The data from patients who were randomized and took at least one dose of blinded study medication in currently available double-blind, randomized short-term comparisons of mirtazapine (1560 mgday; n = 411) and SSRIs (n = 408) (fluoxetine, 20-40 mgday; paroxetine 20-40 mg/day and citalopram, 20-60 mgday) are pooled and analyzed using descriptive statistics. The following variables are presented: percentages of patients complaining of at least one adverse event, percentages of patients prematurely terminating the studies due adverse events and percentages of patients reporting any adverse event. Results: Sixty-five percent of mirtazapine and 63.5% of SF&I-treated patients have complained of at least one adverse event during the studies, respective percentages of patients prematurely discontinuing the studies due to adverse events were 9% for mirtazapine and 8.6% for SSRIs. In either treatment group adverse events were reported in 5 15% of patients. SSRI-treated patients were complaining more frequently than mirtazapine-treated patients of nausea (15 vs 5.3%, respectively) and sweating (8.3 vs 1.5%, respectively). Mirtazapine treated patients complained more frequently of dry mouth (14 vs 6.6%, respectively) and weight increase (10.0 vs 2.7%, respectively). Conclusions: Similar percentages of patients treated with either mirtazapine or SSRIs were complaining of at least one adverse event or prematurely terminated the studies. The overall incidences of reported adverse events were low, and the most frequent complaints are in line with different pharmacological profiles of compounds. It can be concluded that mirtazapine and SSRIs are equally well tolerated during the short-term treatment of major depression.
Ip.1.0641
An open-label, Argentlna
naturalistic
study of mirtazapine
in
J. Pahissa. Organon Argentina, Buenos Aires, Argentina Objective: To assess antidepressant efficacy and tolerability of mirtazapine in everyday clinical practice. Materials and Methods: Depressed in- and outpatients of both sexes (n = 175), older than 18 years, were treated by psychiatrists (n = 60) in Argentina in an open-label study. Efficacy was assessed by 17-item HAMD at baseline and after 7, 21 and 84 days of treatment. Tolerability was assessed by registering treatment-emergent adverse events. The statistical analysis was performed on Intention-to-Treat basis using the Last Observation Carried Forward method. Qualitative variables were compared by Pearson’s chi-square test and Fisher’s exact test and quantitative variables by univariate analyses of Kruskal-Wallis. P values ~0.05 were considered significant. Results: At baseline, 96% of patients were moderately to severely depressed 82% presented with insomnia, 49% with panic symptoms and 31% with suicidality. Mean dose used was 30 mg/day of mirtazapine. Seven percent of patients dropped out due to adverse events. Mean group
Aim: To review data on 19 patients in whom combination therapy with mirtazapine and electroconvulsive therapy (ECT) was used. Materials and Methods: A retrospective review of patients’ charts was performed. Nineteen hospitalized depressed patients (9 females and 10 males, age range between 26 and 85 years) were treated with combination therapy. ECT has been administered unilaterally in 18 patients in a number ranging between 3-16. One patient received 10 bilateral ECTs, and one patient a single bilateral ECT application in during the ECT series. In patients not previously treated with mirtazapine, the drug was introduced during the ECT series, usually at 15 mg/day and towards the end of the series. The combination therapy lead to a quick resolution of depressive symptoms, without any adverse events observed, and enabled discharge of patients the same day or the day after the last ECT. Conclusions: In contrast to other antidepressants, lithium or benzodiazapines which need to be discontinued during the ECT administration, our experience suggest that introduction of mirtazapine or continuation of treatment with mirtazapine during the ECT series is efficaceous and safe procedure. The possible lowering of a seizure threshold of administered ECT by mirtazapine may be advantageous in combination treatment.
Ip.1.0661
Rapid onset of therapeutic action in major depression: a comparative trial of mirtaxapine paroxetine
and
0. Benkert’, A. Szegedi’, R. Kohnen’, A.-J. Schutte3. ‘Johannes Guttenberg-Unioersiriit, Psychitrische Kliniek und Polikliniek, Untere Zuhlbacher Str 8, 55131 Maim; ‘IMEREM, Niiremberg Germany 3NV Organon, Oss, The Netherlands Aim: To compare antidepressant and anxiolytic efficacy as well as tolerability of mirtazapine and paroxetine in a randomized, double-blind, multicentre, 6-weeks’ study. Methods: Outpatients with a Major Depressive Episode-DSM-IV and a baseline score of 2 18 on the 17-HAMD were randomized to 6 weeks’ treatment with either mirtazapine (n = 138, 15-45 mg/day) or paroxetine (n = 136, 20-40 mgday). Efficacy was assessed by the 17-HAMD, HAMA, CGI, and BDI scales, on ITT group using the OC and LOCF methods; and tolerability by the UKU scale and reporting of adverse events. Results: Mean doses were mirtazapine, 32.7 mgday and paroxetine, 22.9 mgday; 24 patients in either treatment group dropped out from the study. Both drugs were equally effective in reducing overall symptoms of depression. At week 1 improvement in 17-HAMD scores was significantly larger under mirtazapine (6 = -6.0 f 5.2) compared to paroxetine (6 = -3.6 f 5.1; p = 0.0004). Significantly more mirtazapine-treated patients were HAMD responders at week 1 (23.8% vs 8.9%, p = 0.002) and week 4 (58.3% vs 44.5%, p = 0.40) Statistically significant differences favoring mirtazapine were also found on other factors/subscales of the HAMD. Tolerability of both treatments was good, with mom complaints of weight increase and influenza-like symptoms in the mirtazapine group, and nausea, vomiting, tremor and sweating in the paroxetine group. Conclusions: Mirtazapine and paroxetine were equally effective and well tolerated. Mirtazapine was significantly more effective than paroxetine especially after the first week of therapy, and consecutively during
PI Affective disorders and antidepressants
present in the MADRS, HAM-A and CC&Severity of Illness and Quality of life scores. Both drugs were well tolerated. Sweating and nausea were significantly more frequent in the citalopram group and increased appetite and weight increase in the mirtazapine group. Conclusions: Mirtazapine and citalopram were equally effective in reducing symptoms of depression and anxiety, and well tolerated. However, mirtazapine was significantly more effective than citalopram after 2 weeks of treatment on MADRS, HAM-A and CGI-Severity of Illness and Quality of life scales. This finding, consistently present at all major efficacy variables, suggests potentially faster onset of action of mirtazapine.
17-HAMD scores were 27 at baseline, and further decreased to a value of 21 at day 7, 14 at day 21 and 6.5 at day 84. The most frequently reported adverse events were somnolence in 17% and weight gain in 2.3% of patients. Conclusion: The results of this open-label study are in line with the results of randomized, double-blind studies of mirtazpaine. They confirm rapid and sustained antidepressant efficacy of mirtazapine combined with a favorable tolerability profile.
Ip.1.0651
Mirtaxapine
and ECT as combination
therapy
B. Soderstrom. Psychiatric Clinic, Varberg Hospital, Varberg, Sweden (p.1.0631
Tolerability of mirtazapine vs SSRls in short term treatment of major depression
C.M.E. Kremer’, J.T.H. Helsdingen, J.A. Schutte, E. Vester. ‘Organon Inc., Mount Pleasant Ave. 375, West Orange, NJ 07052, USA Aim: To compare overall tolerability of mirtazapine versus SSRIs used
in short-term treatment of major depression. Method: The data from patients who were randomized and took at least one dose of blinded study medication in currently available double-blind, randomized short-term comparisons of mirtazapine (1560 mgday; n = 411) and SSRIs (n = 408) (fluoxetine, 20-40 mgday; paroxetine 20-40 mg/day and citalopram, 20-60 mgday) are pooled and analyzed using descriptive statistics. The following variables are presented: percentages of patients complaining of at least one adverse event, percentages of patients prematurely terminating the studies due adverse events and percentages of patients reporting any adverse event. Results: Sixty-five percent of mirtazapine and 63.5% of SF&I-treated patients have complained of at least one adverse event during the studies, respective percentages of patients prematurely discontinuing the studies due to adverse events were 9% for mirtazapine and 8.6% for SSRIs. In either treatment group adverse events were reported in 5 15% of patients. SSRI-treated patients were complaining more frequently than mirtazapine-treated patients of nausea (15 vs 5.3%, respectively) and sweating (8.3 vs 1.5%, respectively). Mirtazapine treated patients complained more frequently of dry mouth (14 vs 6.6%, respectively) and weight increase (10.0 vs 2.7%, respectively). Conclusions: Similar percentages of patients treated with either mirtazapine or SSRIs were complaining of at least one adverse event or prematurely terminated the studies. The overall incidences of reported adverse events were low, and the most frequent complaints are in line with different pharmacological profiles of compounds. It can be concluded that mirtazapine and SSRIs are equally well tolerated during the short-term treatment of major depression.
Ip.1.0641
An open-label, Argentlna
naturalistic
study of mirtazapine
in
J. Pahissa. Organon Argentina, Buenos Aires, Argentina Objective: To assess antidepressant efficacy and tolerability of mirtazapine in everyday clinical practice. Materials and Methods: Depressed in- and outpatients of both sexes (n = 175), older than 18 years, were treated by psychiatrists (n = 60) in Argentina in an open-label study. Efficacy was assessed by 17-item HAMD at baseline and after 7, 21 and 84 days of treatment. Tolerability was assessed by registering treatment-emergent adverse events. The statistical analysis was performed on Intention-to-Treat basis using the Last Observation Carried Forward method. Qualitative variables were compared by Pearson’s chi-square test and Fisher’s exact test and quantitative variables by univariate analyses of Kruskal-Wallis. P values ~0.05 were considered significant. Results: At baseline, 96% of patients were moderately to severely depressed 82% presented with insomnia, 49% with panic symptoms and 31% with suicidality. Mean dose used was 30 mg/day of mirtazapine. Seven percent of patients dropped out due to adverse events. Mean group
Aim: To review data on 19 patients in whom combination therapy with mirtazapine and electroconvulsive therapy (ECT) was used. Materials and Methods: A retrospective review of patients’ charts was performed. Nineteen hospitalized depressed patients (9 females and 10 males, age range between 26 and 85 years) were treated with combination therapy. ECT has been administered unilaterally in 18 patients in a number ranging between 3-16. One patient received 10 bilateral ECTs, and one patient a single bilateral ECT application in during the ECT series. In patients not previously treated with mirtazapine, the drug was introduced during the ECT series, usually at 15 mg/day and towards the end of the series. The combination therapy lead to a quick resolution of depressive symptoms, without any adverse events observed, and enabled discharge of patients the same day or the day after the last ECT. Conclusions: In contrast to other antidepressants, lithium or benzodiazapines which need to be discontinued during the ECT administration, our experience suggest that introduction of mirtazapine or continuation of treatment with mirtazapine during the ECT series is efficaceous and safe procedure. The possible lowering of a seizure threshold of administered ECT by mirtazapine may be advantageous in combination treatment.
Ip.1.0661
Rapid onset of therapeutic action in major depression: a comparative trial of mirtaxapine paroxetine
and
0. Benkert’, A. Szegedi’, R. Kohnen’, A.-J. Schutte3. ‘Johannes Guttenberg-Unioersiriit, Psychitrische Kliniek und Polikliniek, Untere Zuhlbacher Str 8, 55131 Maim; ‘IMEREM, Niiremberg Germany 3NV Organon, Oss, The Netherlands Aim: To compare antidepressant and anxiolytic efficacy as well as tolerability of mirtazapine and paroxetine in a randomized, double-blind, multicentre, 6-weeks’ study. Methods: Outpatients with a Major Depressive Episode-DSM-IV and a baseline score of 2 18 on the 17-HAMD were randomized to 6 weeks’ treatment with either mirtazapine (n = 138, 15-45 mg/day) or paroxetine (n = 136, 20-40 mgday). Efficacy was assessed by the 17-HAMD, HAMA, CGI, and BDI scales, on ITT group using the OC and LOCF methods; and tolerability by the UKU scale and reporting of adverse events. Results: Mean doses were mirtazapine, 32.7 mgday and paroxetine, 22.9 mgday; 24 patients in either treatment group dropped out from the study. Both drugs were equally effective in reducing overall symptoms of depression. At week 1 improvement in 17-HAMD scores was significantly larger under mirtazapine (6 = -6.0 f 5.2) compared to paroxetine (6 = -3.6 f 5.1; p = 0.0004). Significantly more mirtazapine-treated patients were HAMD responders at week 1 (23.8% vs 8.9%, p = 0.002) and week 4 (58.3% vs 44.5%, p = 0.40) Statistically significant differences favoring mirtazapine were also found on other factors/subscales of the HAMD. Tolerability of both treatments was good, with mom complaints of weight increase and influenza-like symptoms in the mirtazapine group, and nausea, vomiting, tremor and sweating in the paroxetine group. Conclusions: Mirtazapine and paroxetine were equally effective and well tolerated. Mirtazapine was significantly more effective than paroxetine especially after the first week of therapy, and consecutively during