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P.1.043Onset of antidepressant efficacy in depressed patients treated with mirtazapine fast dissolving tablet versus sertraline
P1, Affectiue disorders and antidepressants
dose. The diagnosis of both conditions was made according to the criteria of the London Brain l;ank (PD) and DSM-IV (MDDPD). Patients received optimization of the PD pharmacological treatment and brief psychodynamic psychotherapy. Medication period was eight weeks with evaluations at baseline,, week one, two, four, six and eight. Our primary efficacy measurements for MDD-PD were tJ,_A_MD-17, in parallel we assessed changes in PD symptomatology with UPDRS III. The response criteria in the depressive symptomatology were a 50% reduction of more in the baseline I-IAMD-17 score. The remission was defined as a score of 7 or less in HAMD-17 at the end point. Results, From 37 patients screened, 20 were included, 10 for each group, all of them completed the trial. Mean ages were 50.2 years and 56.0 year~ for the placebo and mirtazapine group respectively; 60% were women for the placebo group and 40% for the mirtazapine group. At the end of the trial, the mean changes from baseline on the HAMD-17 and UPDRS III showed greater reduction in the mirtazapin6 group. These changes reached statistical significance only for HAMD-17. More patients were classified as responders and remitters in the mirtazapine group although the difference was not statistically significant. Two patients (one in each group) had more than 25 points in RA_MD-17 at baseline (severe depressive symptomatology). Only the patient in the mirtazapine group met the criteria for response and remission at the end of the trial. No patients dropped out in any treatment group; peripheral ederra was the only adverse event reported by one patient of the mirtazapin6 group. Conelusiom-" Despite the sample size limitations of this trial, our results suggest that mirtazapine is an effective, safe and secure option for the treatment of patients with MDD-PD. The differences in the two severe depressive ~mptomatology eases suggest that mirtazapine will probably be even more helpful in these kinds of patients. Optimization of the pharmacological treatment for PD and brief psychotherapy could be an alternative for patients with moderate depressive symptomatology.
References [1] W h ~ t l ~ DP ~ at, Mirtazapine: effioaoy and tol~abili W in comparison with Pluo×etine in patients with moderate to severe major depressive disorder, J Clin Psy&iatry 199% 59; 6:306-312, [2] Lelnonen E., N.carsteln J., Behnke K., Agren H., Helsdlngen J and The Nordic Antidepressant Study Group. Efficacy and tolerability of mirtazapine versus oitalopi"am: a double blind, randomized study in patients with major depressive disorder. International Ollnloal Psyohopharmaoology 1999, 14; 6: 329-337. [3] Benlcert O., Szegedi A., Kohnen R. Mirtazapine compared with paro×etlne in major depression. J Clln Psy&iatry 2000; 61: 656-663.
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Onset of antidepressant efficacy in depressed patients treated with mirtazapine fast dissolving tablet versus sertraline
R.A. Baker, A.I Schutte. Organon International 7nc., Medical
Services, Roseland, N:, U~S.A. Purpose: Mirtazapine fast dissolving tablet (FDT), a new antidepressant with a unique pharmacologic profile that enhances serotonergic and noradrenergic neurotransmission, has been shown to be an effective and well-tolerated antidepressant with a positive impact on sleep. Restoration of normal sleep is integral to all antidepressant therapy. In the present subanalysis, we examined the onset of sleep improvement between mirtazapine and the selective serotonin re-uptake inhibitor sertraline using the HAM-D Factor VI assessment.
$191
I~ethocls-" Subjects with a major depressive episode (according to DSM-IV criteria) were included and treated with either mirtazapine (using the fast dissolving form) 30-45 me/day or sertraline 50-150 me/day. Subjects aged between 18-70 years with a minimum score of at least 18 on the 17-item t t A M D scale were included. Efficacy was assessed using the Hamilton Depression Rating Scale (I-IAMD) Factor VI measure of "sleep disturbance". To document the speed of onset of sleep irrprovement, assessments were performed on day 4, 7, 10, 14, 28, 42, and 56 after initiation of treatment. This post-hoe analheis was performed using the Intent-to-Treat group and the Last Observation Carried forward approach. Results-" A total of 345 patients were included, 176 were treated with mirtazapine and 169 with sertraline. The mean baseline HAM-D Factor VI score was 4.4 for the mirtazapin6 group, and 4.1 for the sertraline group. The mean change from baseline in total Factor VI score was significantly superior (p<0.001) for the mirtazapine-treated group compared with the sertraline-treated group on all days of assessment: day 4 (-1.3 vs -0.5), day 7(-2.0 vs -1.0), day 10 (-2.1 vs -1.2), day 14 (-2.4 vs -1.6), day 28 (-2.6 vs -1.9), day 42 (-2.8 vs -2.2), and day 56 (-3.0 vs -2.2). Conclusion: The results add to the growing literature on the more rapid onset of antidepressant efficacy of mirtazapine vs SSRIs by showing that patients taking mirtazapin6 also have a significantly more rapid improvement in sleep Nnction than patients taking sertraline. The significant improvement in sleep function for mirtazapine vs sertraline persisted even up to 56 days after initiation of treatment. The results support the hypothesis that improved sleep function contributes to antidepressant efficacy, and raise the possibility that other drugs with combined noradrenevgic and serotonergic receptor binding profiles may have utility as sleep aids.
~ D o e s childhood and adult obsessive compulsive disorder (OCD) respond the same way to treatment with serotonin reuptake inhibitors (SRIs) N, Finebet'~ 1, I, Heyman 2 , R, Jenkins 3, P, Premkumar 3, D, Vea164 , T. Kendall , M. Freeston . QE2-I H~pital, ©epartmem of
Psychiatry, lVelwyn Garden City, United Kingdom; 2The Maudsley Hospital, Department of P~yc#iatry, London, United Kingdom; 3~oyal College of Psychiatrists, College ~esearc~ Unit, London, United Kingdom; 4The _Priory Hospital, Department of _Psychiatry, London, United Kingdom; 5~oyal F~ctoria Infirmary, Department of Psyc~olo£~, Newcastle, United Kingdom
Purpose of Study: Meta-analyses of placebo-controlled, randomised trials (RCTs) of SRIs in adult and childhood OCD were compared to assess differential efficacy and tolerability based on age group. Metho& All available published, acute phase, placebocontrolled RCTs looking at clomipramine and SS~RIs as treatment for OCD were identified through a systematic literature search. Studies where it was not possible to extract data for drug-placebo comparisons (e.g. absence of point estimates and standard deviations or other recognised variability measures) were excluded. Efficacy was measured as responder rates and treatment end-point or change from baseline scores on the Y-1;©CS, CY-1;©CS and NIIvlI-I-OC scales. Adverse events and associated dropout rates were also examined. Extracted data were analysed using Review Manager ,1.2 software (Cochrane Collaboration, 2002). Studies
dose. The diagnosis of both conditions was made according to the criteria of the London Brain l;ank (PD) and DSM-IV (MDDPD). Patients received optimization of the PD pharmacological treatment and brief psychodynamic psychotherapy. Medication period was eight weeks with evaluations at baseline,, week one, two, four, six and eight. Our primary efficacy measurements for MDD-PD were tJ,_A_MD-17, in parallel we assessed changes in PD symptomatology with UPDRS III. The response criteria in the depressive symptomatology were a 50% reduction of more in the baseline I-IAMD-17 score. The remission was defined as a score of 7 or less in HAMD-17 at the end point. Results, From 37 patients screened, 20 were included, 10 for each group, all of them completed the trial. Mean ages were 50.2 years and 56.0 year~ for the placebo and mirtazapine group respectively; 60% were women for the placebo group and 40% for the mirtazapine group. At the end of the trial, the mean changes from baseline on the HAMD-17 and UPDRS III showed greater reduction in the mirtazapin6 group. These changes reached statistical significance only for HAMD-17. More patients were classified as responders and remitters in the mirtazapine group although the difference was not statistically significant. Two patients (one in each group) had more than 25 points in RA_MD-17 at baseline (severe depressive symptomatology). Only the patient in the mirtazapine group met the criteria for response and remission at the end of the trial. No patients dropped out in any treatment group; peripheral ederra was the only adverse event reported by one patient of the mirtazapin6 group. Conelusiom-" Despite the sample size limitations of this trial, our results suggest that mirtazapine is an effective, safe and secure option for the treatment of patients with MDD-PD. The differences in the two severe depressive ~mptomatology eases suggest that mirtazapine will probably be even more helpful in these kinds of patients. Optimization of the pharmacological treatment for PD and brief psychotherapy could be an alternative for patients with moderate depressive symptomatology.
References [1] W h ~ t l ~ DP ~ at, Mirtazapine: effioaoy and tol~abili W in comparison with Pluo×etine in patients with moderate to severe major depressive disorder, J Clin Psy&iatry 199% 59; 6:306-312, [2] Lelnonen E., N.carsteln J., Behnke K., Agren H., Helsdlngen J and The Nordic Antidepressant Study Group. Efficacy and tolerability of mirtazapine versus oitalopi"am: a double blind, randomized study in patients with major depressive disorder. International Ollnloal Psyohopharmaoology 1999, 14; 6: 329-337. [3] Benlcert O., Szegedi A., Kohnen R. Mirtazapine compared with paro×etlne in major depression. J Clln Psy&iatry 2000; 61: 656-663.
•
Onset of antidepressant efficacy in depressed patients treated with mirtazapine fast dissolving tablet versus sertraline
R.A. Baker, A.I Schutte. Organon International 7nc., Medical
Services, Roseland, N:, U~S.A. Purpose: Mirtazapine fast dissolving tablet (FDT), a new antidepressant with a unique pharmacologic profile that enhances serotonergic and noradrenergic neurotransmission, has been shown to be an effective and well-tolerated antidepressant with a positive impact on sleep. Restoration of normal sleep is integral to all antidepressant therapy. In the present subanalysis, we examined the onset of sleep improvement between mirtazapine and the selective serotonin re-uptake inhibitor sertraline using the HAM-D Factor VI assessment.
$191
I~ethocls-" Subjects with a major depressive episode (according to DSM-IV criteria) were included and treated with either mirtazapine (using the fast dissolving form) 30-45 me/day or sertraline 50-150 me/day. Subjects aged between 18-70 years with a minimum score of at least 18 on the 17-item t t A M D scale were included. Efficacy was assessed using the Hamilton Depression Rating Scale (I-IAMD) Factor VI measure of "sleep disturbance". To document the speed of onset of sleep irrprovement, assessments were performed on day 4, 7, 10, 14, 28, 42, and 56 after initiation of treatment. This post-hoe analheis was performed using the Intent-to-Treat group and the Last Observation Carried forward approach. Results-" A total of 345 patients were included, 176 were treated with mirtazapine and 169 with sertraline. The mean baseline HAM-D Factor VI score was 4.4 for the mirtazapin6 group, and 4.1 for the sertraline group. The mean change from baseline in total Factor VI score was significantly superior (p<0.001) for the mirtazapine-treated group compared with the sertraline-treated group on all days of assessment: day 4 (-1.3 vs -0.5), day 7(-2.0 vs -1.0), day 10 (-2.1 vs -1.2), day 14 (-2.4 vs -1.6), day 28 (-2.6 vs -1.9), day 42 (-2.8 vs -2.2), and day 56 (-3.0 vs -2.2). Conclusion: The results add to the growing literature on the more rapid onset of antidepressant efficacy of mirtazapine vs SSRIs by showing that patients taking mirtazapin6 also have a significantly more rapid improvement in sleep Nnction than patients taking sertraline. The significant improvement in sleep function for mirtazapine vs sertraline persisted even up to 56 days after initiation of treatment. The results support the hypothesis that improved sleep function contributes to antidepressant efficacy, and raise the possibility that other drugs with combined noradrenevgic and serotonergic receptor binding profiles may have utility as sleep aids.
~ D o e s childhood and adult obsessive compulsive disorder (OCD) respond the same way to treatment with serotonin reuptake inhibitors (SRIs) N, Finebet'~ 1, I, Heyman 2 , R, Jenkins 3, P, Premkumar 3, D, Vea164 , T. Kendall , M. Freeston . QE2-I H~pital, ©epartmem of
Psychiatry, lVelwyn Garden City, United Kingdom; 2The Maudsley Hospital, Department of P~yc#iatry, London, United Kingdom; 3~oyal College of Psychiatrists, College ~esearc~ Unit, London, United Kingdom; 4The _Priory Hospital, Department of _Psychiatry, London, United Kingdom; 5~oyal F~ctoria Infirmary, Department of Psyc~olo£~, Newcastle, United Kingdom
Purpose of Study: Meta-analyses of placebo-controlled, randomised trials (RCTs) of SRIs in adult and childhood OCD were compared to assess differential efficacy and tolerability based on age group. Metho& All available published, acute phase, placebocontrolled RCTs looking at clomipramine and SS~RIs as treatment for OCD were identified through a systematic literature search. Studies where it was not possible to extract data for drug-placebo comparisons (e.g. absence of point estimates and standard deviations or other recognised variability measures) were excluded. Efficacy was measured as responder rates and treatment end-point or change from baseline scores on the Y-1;©CS, CY-1;©CS and NIIvlI-I-OC scales. Adverse events and associated dropout rates were also examined. Extracted data were analysed using Review Manager ,1.2 software (Cochrane Collaboration, 2002). Studies