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

Abstract

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, > or =50% reduction in HAMD total score from baseline), HAMD remission rate (HAMD total score of < or =7), and the Montgomery-Asberg 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.

Efficacy, tolerability, and preference of mirtazapine orally disintegrating tablets in depressed patients: a 17-week naturalistic study in Lithuania

“…In our study, we have observed significant changes in mood, suicidal ideation items, anxiety and insomnia clusters during the first week of treatment with mirtazapine ODT. Rapid reduction of suicidal thoughts and anxiety is in line with data of other naturalistic studies and previous clinical studies, showing that mirtazapine has a faster onset of action compared to paroxetine, sertraline, or venlafaxine extended-release tablets (16)(17)(18)(19). Referring to the Lithuanian situation with a very high number of suicides, it is important to have rapid acting antidepressants like mirtazapine ODT (20).…”

Effectiveness and medication acceptance of olanzapine disintegrating tablets compared to standard olanzapine tablets in acutely treated psychiatric patients

“…Removal of ODT from the tongue is also more diffi cult than for the standard (coated) olanzapine tablet (SOT) since it forms an amorphous residue that can only be removed by scraping the tongue. The use of orally disintegrating tablets in other indications (eg, migraine, depression), has been successfully tested in other studies (Dowson et al 2002;Behnke et al 2003). Improved compliance has, besides improved cognitive functioning and reduced negative symptoms, also been identifi ed as a possible factor leading to a decrease in suicidality (Meltzer et al 1998).…”

Discussion of Prevalence and Management of Discomfort When Swallowing Pills: Orodispersible Tablets Expand Treatment Options in Patients With Depression

“…In a global questionnaire study of patients' perceptions of mirtazapine ODT (n = 5428), 86% reported finding it easy to use and had a positive impression of this formulation. These opinions translated into a greater preference for mirtazapine ODT compared with ordinary tablets (62.1% preferred the ODT) and increased rates of compliance (47.3% of patients reported that their compliance had improved) [57].…”