Once-a-Day Trazodone in the Treatment of Depression in Routine Clinical Practice

Abstract

Objective: The aim of the study was to evaluate the efficacy, tolerability, and safety of once-a day trazodone tablets (Trittico Prolong® 300 mg) in patients with moderate to severe depression in routine clinical practice. Methods: Men and women ≥18 years old with Montgomery-Åsberg Depression Rating Scale (MADRS) scores > 21 and Clinical Global Impression – Severity (CGI/S) ≥4 were included in this post-authorization, non-interventional, observational prospective safety study, conducted in 8 psychiatric centers in the Czech ­Republic. The acute treatment phase lasted 5 weeks: 1 week of titration and 4 weeks of full-dose treatment. Patients had follow-up visits 9 and 21 weeks after commencing ­treatment. Results: Overall, 85 patients were enrolled in the study, of which 80 completed the acute treatment of 5 weeks. There were significant decreases in the overall MADRS score from the baseline mean value of 27.4–21.2 at week 1 (p < 0.001), and a further decrease to 7.9 at week 5 (p < 0.001). The severity of depression according to CGI/S gradually declined. Most patients reported improvement after 6 days of trazodone treatment. The most frequent adverse drug reactions (ADRs) reported were somnolence and fatigue. Conclusions: Trazodone, in the new extended-release formulation, had very good effects in clinical practice, both in previously untreated depressive episodes and in episodes not responsive to previous antidepressive therapy.

Treating Depression in Clinical Practice: New Insights on the Multidisciplinary Use of Tradozone

“…A recent HDRS17 factor reanalysis of the two studies found that the faster antidepressant effects of trazodone were not only exerted, as expected, on the sleep component of depressive symptoms, but also on the cognitive aspects of depression [33]. These results seemed to be in line with a previous report of the rapid antidepressant efficacy of trazodone OAD (1 week) in a clinical practice setting, as measured using the Montgomery-Asberg Depression Rating Scale (MADRS) [37]. Moreover, early studies had already found that trazodone IR resulted in a greater reduction in 1 week treatment at the HDRS as compared to bupropion and fluoxetine [38,39] as well as to trazodone PR vs. a placebo [40].…”

Early response to trazodone once-a-day in major depressive disorder: review of the clinical data and putative mechanism for faster onset of action

“…23,24 The antidepressant efficacy, combined with improved tolerability and improvements in sleep disturbance observed with trazodone OAD, may have important clinical implications, like enhanced compliance and decreased use of concomitant medications. In fact, the observational study conducted by Češková et al 41 showed that adherence with trazodone OAD formulation was high (>70%) after 21 weeks of treatment. The study also reported a significant reduction in the need for concomitant medications, such as anxiolytics, hypnotics, and other psychotropic medications.…”

“…Most patients reported improvement in the overall severity of their illness as assessed by the Clinical Global Impression-Severity scale after 6 days of treatment, thus demonstrating that the early improvement observed with trazodone was clinically meaningful. 41,50 This suggests that early onset of antidepressant action is a specific characteristic of trazodone. Early improvement with antidepressants has important clinical implications.…”

“…40 The medication was first approved for use by the Food and Drug Administration in 2010 and in Europe in 2014. 41,42 The articles included in this review were identified using the following search terms: ((trazodone [Title/ Abstract]) AND (once a day [Title/Abstract])) OR ((trazodone [Title/Abstract]) AND (once daily [Title/Abstract])) OR ((trazodone [Title/Abstract]) AND (once-a-day [Title/Abstract])). The studies of trazodone IR and PR formulations were excluded from this review because their pharmacokinetic profiles are distinct from that of the OAD formulation, and the doses needed to generate an antidepressant response may be associated with adverse effects, such as sedation, that may limit their use as antidepressants.…”

An Observational Pilot Study using a Digital Phenotyping Approach in Patients with Major Depressive Disorder Treated with Trazodone

“…Since its approval, the antidepressant efficacy and the favorable tolerability profile of trazodone have been confirmed in several pharmacological and clinical studies (27,28). Results have demonstrated that trazodone was as effective as other antidepressant classes in the management of depressive disorders (26, [29][30][31][32][33][34][35].…”