Mirtazapine monotherapy versus combination therapy with mirtazapine and aripiprazole in depressed patients without psychotic features: a 4-week open-label parallel-group study.

BACKGROUND: There is preliminary evidence that the atypical antipsychotic aripiprazole, which is a partial agonist at D(2) and 5-HT(1A) receptors and a potent antagonist at 5-HT(2A) receptors, may be useful as an augmentation strategy in treatment-resistant depression. METHOD: In this 4-week open-label non-randomized parallel-group study, the safety and efficacy of aripiprazole as add-on treatment strategy in patients suffering from non-delusional depression was investigated. Forty drug-free depressed inpatients without psychotic symptoms (13 men, 27 women), suffering from a major depressive episode or bipolar disorder, depressive state (DSM-IV criteria), were included in the study. The patients were treated either with mirtazapine monotherapy (45 mg/day) or combination therapy (mirtazapine 45 mg/day plus aripiprazole 15 mg/day) for 4 weeks. Safety and efficacy were assessed weekly using the Hamilton Depression Rating Scale, the Simpson-Angus Scale and the Barnes Akathisia Scale. RESULTS: Mirtazapine monotherapy and combined treatment with mirtazapine and aripiprazole showed comparable antidepressant effects as assessed at the endpoint of the study period. However, additional administration of aripiprazole accelerated the onset of antidepressant action in patients suffering from treatment-resistant depression. Additive use of aripiprazole reduced the mirtazapine-induced increase in the body mass index. Moreover, mirtazapine had favourable effects on aripiprazole-induced akathisia. No other extrapyramidal side effects were seen in the combination therapy group. CONCLUSION: Combined therapy with mirtazapine and aripiprazole is a safe and well-tolerated treatment option which may be useful especially in treatment-resistant depression. Double-blind controlled studies are needed to further explore the efficacy and safety of aripiprazole in depressed patients.

The impact of reboxetine and mirtazapine on driving simulator performance and psychomotor function in depressed patients.

OBJECTIVE: The aim of the present study was to examine the influence of reboxetine and mirtazapine on psychomotor functions related to driving skills and on driving simulator performance in depressed inpatients. METHOD: Forty depressed inpatients diagnosed according to DSM-IV-TR criteria were randomly assigned to treatment with either reboxetine (N = 20) or mirtazapine (N = 20). To control for retest effects in psychomotor measures, a group of 10 healthy controls was examined on the same time schedule. Participants were tested once before pharmacologic treatment and twice after initiation of treatment (days 7 and 14) with computerized tests related to car-driving skills. Data were collected with the Act and React Testsystem ART-90 and the Wiener Testsystem, measuring visual perception, reactivity, stress tolerance, concentration, and vigilance. In addition, patients went through various risk simulations on a static driving simulator. Data were analyzed with nonparametric statistics and repeated-measures analysis of variance. The study was conducted from June 2004 through June 2006. RESULTS: Before onset of treatment with antidepressants, about 65% of patients did not reach the threshold criterion according to the German guidelines for road and traffic safety. After 14 days of treatment with reboxetine or mirtazapine, patients improved in driving ability skills. Controlling for retest effects in psychomotor measures, data indicate that both patient groups significantly improved in tests measuring selective attention and reactivity (all p < .01). Furthermore, the frequency of accidents in the risk simulations markedly decreased in patients receiving mirtazapine and reboxetine (all p < .05). Statistically significant differences between treatment groups could not be shown. CONCLUSION: Our results indicate that partially remitted depressed inpatients treated with reboxetine or mirtazapine show a better performance on tasks related to driving skills than do untreated depressives.