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.

Long-term safety and efficacy of cabergoline for the treatment of idiopathic restless legs syndrome: results from an open-label 6-month clinical trial.

STUDY OBJECTIVES: To assess the safety and efficacy of cabergoline in the treatment of idiopathic restless legs syndrome (RLS) patients. DESIGN: Open-label intervention study for 26 weeks; no control group. SETTING: 302 patients (73% women, aged 61 +/- 11 years) from 37 German neurologic outpatient departments and private practices. INTERVENTION: Cabergoline was upwardly titrated over 4 weeks to individually optimized dosages. Median treatment duration was 181 days. The median daily dose of cabergoline was 1.5 mg. MEASUREMENTS: Drug safety was assessed by adverse events; efficacy was evaluated with the RLS-6 and the International RLS Rating Scales. RESULTS: In 48% of the study participants, investigators reported adverse events suspected to be drug related. Most adverse events were mild and transient and related to the gastrointestinal system (nausea: 16.6%) or the central nervous system (dizziness: 7.0%, headache: 4.6%). Premature dropout from the study occurred in 54 patients (17.9%), in 17 patients (3.0%) due to a drug-related adverse event. The severity of RLS symptoms at night, at bedtime, and during the day, as well as the International RLS Rating Scale total score improved during therapy. Satisfaction with sleep was increased (all P values < .001). In 5% of all patients, RLS symptoms worsened, and in a further 6.3%, response to therapy was poor. In 9 patients (3.0%) between 1 and 3 criteria for augmentation were noted. CONCLUSIONS: Long-term therapy with cabergoline is a safe and well-tolerated treatment option for the great majority of patients with idiopathic RLS. The treatment was efficacious both for nighttime and daytime symptoms in this indication and may carry a low risk of augmentation.