Mirtazapine orally disintegrating tablets versus venlafaxine extended release - A double-blind, randomized multicenter trial comparing the onset of antidepressant response in patients with major depressive disorder
This randomized, multicenter, double-blind study was designed to compare specifically the onset of antidepressant action of mirtazapine orally disintegrating tablets (ODT) with venlafaxine extended-release (XR) formulation in outpatients with major depression. Both treatments were administered in a rapidly escalating dosing regimen. Target doses (mirtazapine ODT, 45 mg OD; venlafaxine XR, 225 mg OD) were reached by day 6 of treatment. On the primary efficacy parameter [the average of the change in HAM-D (17-item) total score on days 5, 8, 11, and 15], mirtazapine ODT was significantly superior to venlafaxine XR (P = 0.008). In addition, calculating the HAM-D score without the sleep items resulted in significant reductions in favor of mirtazapine ODT on days 8 (P = 0.006) and 11 (P = 0.037). The proportion of responders (HAM-D decrease of > or =50% from baseline) was higher in the mirtazapine ODT group on all assessment days, being significant on days 8 (P = 0.002), 11 (P = 0.004), and 22 (P = 0.027). More patients in the mirtazapine ODT group achieved remission (HAM-D total score of < or =7) up to day 29, and the difference was statistically significant on day 15 (P = 0.016). Significant differences in favor of mirtazapine ODT were evident in the CGI of change on days 8 (P = 0.019), 11 (P = 0.004), and 15 (P = 0.031), and the CGI of severity on days 8 (P = 0.014) and 11 (P = 0.033). Both treatments were well tolerated. These results indicate that mirtazapine ODT has a faster onset of antidepressant efficacy than venlafaxine XR in patients with major depressive disorder, and that this effect is independent of its sleep-improving properties.
Available from: Alan G Wade
- "Compliance with medication is a significant problem in most chronic diseases and particularly so for depression. The impact of the formulation of the medication on compliance cannot be determined with confidence from this study but a significantly higher proportion of patients thought that a tablet that melted in the mouth would make it easier to take regularly than those who thought that it would not make a difference, which is in accord with results reported by Roose11 and Benkert et al12 for mirtazapine. Overall, the results demonstrate that there is a real need for an antidepressant tablet that is easy to take. "
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ABSTRACT: To assess the attitudes and preferences of patients currently being treated for depression or anxiety disorders with traditional oral antidepressants relative to a placebo orodispersible (ODT) formulation of escitalopram.
This was an open study collecting patient-reported outcome data from patients with anxiety or depression that were treated with oral antidepressant medication on Day 0 before and after receiving a single placebo ODT, and on Day 3 or 4 after receiving two further daily doses of placebo ODT. Patients aged 18-80 years who were currently receiving treatment with oral antidepressants were recruited from general practice and by advertising. Patients with significant symptoms of anxiety or depression (scoring ≥9 on either the depression or anxiety subscales of the Hospital Anxiety and Depression Scale) were included in the study.
A total of 150 patients were enrolled in and completed the study. About 37% of the patients had had trouble with swallowing tablets, and patients with higher depression scores reported more general swallowing problems than those with lower scores (P = 0.002). Most patients (75.3%) believed that an ODT might work faster but that it would make no difference to the effectiveness of the medication (63.1%) or the number of side effects (81.3%). About 96% of the patients reported experiencing a pleasant taste following the placebo ODT, although seven patients did not like its taste or aftertaste. This study found that 80.7% of patients reported that the tablets were easy or very easy to get out of the packaging.
Based on the results of the placebo version of escitalopram ODT, the escitalopram ODT is likely to be well accepted by patients suffering from anxiety or depressive symptoms.
Available from: Tineke van Veen
- "With our expanded search, we obtained 17 additional articles on AETs (Fabre et al. 1995 ; DeMartinis et al. 1996 ; Stahl, 2000 ; Dinan, 2001 ; Detke et al. 2002 ; Golden et al. 2002 ; Goldstein et al. 2002, 2004 ; Bielski et al. 2004 ; Trivedi et al. 2004 ; Derubeis et al. 2005 ; Fava et al. 2005 ; Sir et al. 2005 ; Benkert et al. 2006 ; Langworth et al. 2006 ; Mulder et al. 2006 ; Shelton et al. 2006). No additional exclusion criteria for AETs were identified. "
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ABSTRACT: Generalizability of antidepressant efficacy trials (AETs) to daily practice is questioned because of their very stringent patient selection. This study aims to determine eligibility for AETs of out-patients suffering from major depression in a routine out-patient setting and investigates influence of eligibility on treatment outcome.
Data collection (n = 1653) was performed through routine outcome monitoring by independent trained research nurses. The Mini-International Neuropsychiatric Interview Plus and the Dimensional Assessment of Personality Pathology, short Dutch version were used for diagnostic assessment and personality pathology screening. The Montgomery-Asberg Depression Rating Scale (MADRS) was used for assessment of baseline severity and treatment outcome. Eligibility was assessed by stepwise application of commonly used exclusion criteria. Influence of eligibility on treatment outcome was investigated in a subsample of the 1653 patients who had at least one follow-up assessment (n = 626). Eligible and non-eligible patients were compared on proportion of response (50% reduction) and remission on MADRS (MADRS ≤ 10).
Altogether, 17-25% of the patients were eligible for AETs. The most common reasons for exclusion would be 'not meeting minimum baseline severity' and 'presence of co-morbid Axis I disorder'. Eligible and non-eligible patients did not differ in treatment outcome. Only 'meeting the minimum baseline severity' is associated with remission.
The majority of 'real life' out-patients are not eligible for AETs. However, the influence of eligibility on treatment outcome seems to be small. This suggests that stringent patient selection by eligibility criteria is not the major reason for lack of generalizability of AETs. Exclusion of less severely depressed patients from the analyses resulted in better treatment outcome. Milder depression is highly prevalent in daily practice and more research into treatment effectiveness in milder depression is warranted.
Available from: Feryal Cam Celikel
- "Son yýllarda yazýlmýþ çeþitli makalelerde, major depresyonu olan hastalarda farklý grup antidepresanlarýn çift-kör karþýlaþtýrmalý çalýþmalarý analiz edilmiþtir (Benkert ve ark. 2006, Posternak ve Zimmerman 2005, Behnke ve ark. 2003, Hirschfeld 2002, Thompson 2002, Schatzberg ve ark. 2002). Mirtazapinin amitriptilin ile karþýlaþtýrýldýðý çalýþmalarda (Smith ve ark. 1990, Mullin ve ark. 1996, Özcankaya 2001) tedavi etkinliklerinin farklý olmadýðý ancak mirtazapinde daha erken baþladýðý bildirilmiþtir. Özcankaya ve ar"
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