Efficacy and Safety of Prolonged-Release Trazodone in Major Depressive Disorder: A Multicenter, Randomized, Double-Blind, Flexible-Dose Trial

Zhang, Lin; Xie, Weiwei; Li, Lehua; Zhang, Honggeng; Wang, Gang; Chen, Dachun; Cao, Yi; Cui, Lijun; Zhang, Kerang; Shi, Jiannong; Tan, Qingrong; Zheng, Hongbo; Xu, Xiufeng; Cheng, Zao-huo; Zhao, Jingping

doi:10.1159/000368559

Cited by 16 publications

(16 citation statements)

References 9 publications

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“…29,31,32 In fact, this early antidepressant efficacy of trazodone OAD was also observed in studies of other trazodone formulations (including the IR and PR formulations). 27,30,47 Overall, the percentage reduction of the HAM-D score after 7 days of treatment with trazodone (all formulations) ranged from 18% to 33%. 27,30,44,45,47 While the pharmacokinetic profiles of the IR and PR formulations may limit the treatment tolerability and compliance in patients due to the need for multiple dosing during the day, the early antidepressant response observed with trazodone regardless of the formulation further lends supporting evidence for early response in depression with trazodone treatment.…”

Section: Discussionmentioning

confidence: 96%

“…Results from doubleblind, randomized clinical trials of trazodone IR and PR formulations demonstrating its faster onset of antidepressant action are summarized in Table 1. 27,30,46,47 Efficacy of the trazodone OAD formulation for improvement in the HAM-D17 factors Depression is a multifaceted disorder, which is characterized by depressed mood along with several significant psychological, cognitive, and behavioral components. Different antidepressants, based on their pharmacological profile, may initiate improvement in various clinical components at different rates.…”

Section: Early Improvement Of Depressive Symptoms With Trazodone Oad Formulationmentioning

confidence: 99%

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

2021

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Background Most antidepressants have a delayed onset of action and must be administered for several weeks to generate therapeutic effects. Trazodone is a serotonin antagonist and reuptake inhibitor approved for the treatment of major depressive disorder. The once-a-day (OAD) formulation of trazodone has an improved tolerability profile compared to its conventional formulations. In this study, we systematically reviewed the evidence available for the antidepressant efficacy and early improvement in depressive symptoms with trazodone OAD treatment. Method We conducted a PubMed database search for randomized controlled trials published from 2005 to 2020. Results Two studies, a placebo-controlled and an active-comparator (venlafaxine extended-release or XR) study were found. Both the studies demonstrated that trazodone exhibits antidepressant activity at a starting dose of 150 mg/day and results in statistically significant greater reduction in Hamilton Depression Rating Scale (HAM-D17) scores within 1 week of starting treatment compared to placebo or venlafaxine XR (P < .05). Trazodone also resulted in significant early improvement in the HAM-D17 sleep disturbance factor compared to placebo or venlafaxine XR at day 7 (P < .05). This clinical effect is supported by in vitro proprietary data for the affinity of trazodone for different target receptors. Activity at these receptors may underlie trazodone’s fast antidepressant action. Conclusions Trazodone, if properly dosed, can be an effective antidepressant with early onset of action and good tolerability. Future studies designed to specifically evaluate onset and timing of improvement of depressive symptoms remain necessary to confirm and extend these results.

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Section: Discussionmentioning

confidence: 96%

Section: Early Improvement Of Depressive Symptoms With Trazodone Oad Formulationmentioning

confidence: 99%

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

2021

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“…There are many studies with trazodone covering almost all aspects of safety and efficacy of this medication, including the recently published Chinese randomized placebo-controlled flexible-dose trial with prolonged-release trazodone [9] and Serbian non-interventional, open label post-marketing study with the same product [10]. However, there is only one controlled study published with the new one-daily formulation of trazodone [5].…”

Section: Discussionmentioning

confidence: 99%

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

Češková

Šedová²,

Kellnerová³

et al. 2018

Pharmacology

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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.

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“…Trazodone hydrochloride has been used in human patients as an antidepressant 38,39 and anxiolytic 40,41 for many years. A member of the phenylperazine class of drugs, trazodone is classified as a serotonin antagonist and reuptake inhibitor owing to its primary pharmacological mechanism as an antagonist at serotonin 2A receptors and its secondary mechanism as a serotonin reuptake inhibitor.…”

Section: Small Animalsmentioning

confidence: 99%

Effects of trazodone on behavioral signs of stress in hospitalized dogs

Gilbert-Gregory¹,

Stull²,

Rice³

et al. 2016

javma

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OBJECTIVE To determine the effects of trazodone treatment on behavioral signs of stress in hospitalized dogs. DESIGN Prospective observational study. ANIMALS 120 client-owned dogs. PROCEDURES Hospitalized dogs administered trazodone (n = 60) were observed for stress-related signs or behaviors ≤ 45 minutes after the drug was administered (time 1) and approximately 90 minutes later (time 2). Dogs that did not receive trazodone (n = 60) were selected to serve as controls for environmental stimuli that could affect behavior and were observed at the same times. Signs or behaviors (scored as present or absent) were assessed individually and grouped into behavioral summation categories (frenetic [lip licking, pacing, panting, spinning, trembling, wet dog shake, whining, and yawning], freeze [averting gaze, pinning back ears, and whale eye sign], or fractious [growling, lunging, showing teeth, and snapping], with lifting of a forelimb and pupil dilation included in all categories). Results were compared between groups and within groups over time. Logistic regression was performed to assess associations between reduction in stress-related signs or behaviors and trazodone administration while controlling for environmental influences. RESULTS Lip licking, panting, and whining were reduced (defined as present at time 1 and absent at time 2) in trazodone-treated but not environmentally matched dogs. The median number of stress-related behaviors and of frenetic and freeze behaviors was significantly lower at time 2, compared with time 1, in trazodone-treated dogs. Odds of reduced panting and reduced frenetic behaviors at time 2 for trazodone-treated dogs were > 2 times those for environmentally matched dogs. CONCLUSIONS AND CLINICAL RELEVANCE Results indicated that trazodone administration reduced stress-related signs and behaviors in hospitalized dogs and may thereby improve patient welfare.

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Efficacy and Safety of Prolonged-Release Trazodone in Major Depressive Disorder: A Multicenter, Randomized, Double-Blind, Flexible-Dose Trial

Cited by 16 publications

References 9 publications

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

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

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

Effects of trazodone on behavioral signs of stress in hospitalized dogs

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