PracticeUpdate Conference Series European Congress of Psychiatry 2019

Trazodone OAB Proves Non-Inferior to Venlafaxine XR for Major Depressive Disorder Significant improvements were seenwith trazodone in just 1 week. A once daily formulation of trazodone (trazo- done OAD) was shown to be non-inferior to venlafaxine extended release (venlafaxine XR) for the treatment of major depressive dis- order in a 2-month trial. The study results were presented at EPA 2019. In a double-blind, parallel-design study, research- ers led by Enrica Salvatori of Angelini S.p.A. in Rome, Italy randomized 324 patients with major depressive disorder to treatment with trazodone OAD 300 mg (n=166) or venlafaxine XR 75 mg (n=158) once daily. The primary efficacy endpoint of the study was to demonstrate the non-infe- riority of trazodone OAD, based on a change from baseline in the 17-item Hamilton Depression Rating Scale (HAM-D) total score from baseline to final visit on Day 56. Both treatments were found to be effective. Based on an intent-to-treat analysis, the mean reduction in HAM-D total score was –12.9 ± 6.82 with trazodone OAD and –14.7 ± 6.56 with venlafaxine XR. Similarly, using a per-protocol analysis, mean reduction in HAM-D was –15.4 ± 5.32 with trazodone OAD and –16.4 ± 5.39 with venlafaxine XR. In both cases, trazodone OAD was found to be non-inferior to venlafaxine XR. Notably, patients treated with trazodone OAD achieved a statistically significant reduction in the HAM-D total score after only 7 days of treatment. Among patients treated with trazodone OAB, the most frequent adverse events reported were dizziness and somnolence. Among those treated with venlafaxine XR, they were nausea and headache. In both groups, adverse events were usually mild-to-moderate in severity. In their poster, the authors concluded that, “this trial confirmed that trazodone OAD and venla- faxine XR represent an effective and relatively safe therapeutic option for patients with [major depressive disorder]; moreover, trazodone OAD was able to reduce [major depressive disorder] symptoms after only 7 days of treatment, provid- ing a fast onset of action.”

In a comment on the study for Elsevier’s PracticeUpdate , Dennis Butler, PhD, Professor Emeritus of Family Medicine at the Medical College of Wisconsin in Milwaukee, pointed out that “an oft-repeated belief about recurrence of major depressive disorder is that 50% of patients with a first episode will have a second episode and 85% of those with a second episode will have a third. The percentages tumble to near 100% after that. “Since the majority of depressed patients are diagnosed and treated in primary care, it’s tempting to take the results of this study and start identifying patients from your panel who have the risk factors,” he continued. “However, being able to proactively predict which patients will have another bout of depression is still a challenge. Among the key factors identified from the multivariate analysis, it does appear that delays in seeking treatment for a first episode and duration of the depressive episode were powerful influences on the likelihood of recurrence. “The importance of this research lies in the emphasis on the need for maintenance therapy and patient education,” concluded Dr. Butler. “Most first- episode patients would prefer to only have one episode of depression, and many will resist ‘dire’ predictions about recurrence. Make sure to encourage your first-episode depressed patients to return for routine re-evaluation and provide them with symptom checklists which can be completed at regular intervals.” " The importance of this research lies in the emphasis on the need for maintenance therapy and patient education. "

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EPA 2019 • PRACTICEUPDATE CONFERENCE SERIES