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A systematic, updated review on the antidepressant agomelatine focusing on its melatonergic modulation.

ABSTRACT: OBJECTIVE:To present an updated, comprehensive review on clinical and pre-clinical studies on agomelatine. METHOD:A MEDLINE, Psycinfo and Web of Science search (1966-May 2009) was performed using the following keywords: agomelatine, melatonin, S20098, efficacy, safety, adverse effect, pharmacokinetic, pharmacodynamic, major depressive disorder, bipolar disorder, Seasonal Affective Disorder (SAD), Alzheimer, ADHD, Generalized Anxiety Disorder (GAD), Panic Disorder (PD), Obsessive-Compulsive Disorder (OCD), anxiety disorders and mood disorder. STUDY COLLECTION AND DATA EXTRACTION: All articles in English identified by the data sources were evaluated. Randomized, controlled clinical trials involving humans were prioritized in the review. The physiological bases of melatonergic transmission were also examined to deepen the clinical comprehension of agomelatine' melatonergic modulation. DATA SYNTHESIS:Agomelatine, a melatonergic analogue drug acting as MT(1)/MT(2) agonist and 5-HT(2C) antagonist, has been reported to be an effective antidepressant therapy. CONCLUSIONS:Although a bias in properly assessing the "sleep core" of depression may still exist with current screening instruments, therefore making difficult to compare agomelatine' efficacy to other antidepressant ones, comparative studies showed agomelatine to be an intriguing option for depression and, potentially, for other therapeutic targets as well.

SUBMITTER: Fornaro M

PROVIDER: S-EPMC3001221 | biostudies-literature | 2010 Sep

REPOSITORIES: biostudies-literature

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A systematic, updated review on the antidepressant agomelatine focusing on its melatonergic modulation.

Fornaro Michele M Prestia Davide D Colicchio Salvatore S Perugi Giulio G

Current neuropharmacology 20100901 3

<h4>Objective</h4>To present an updated, comprehensive review on clinical and pre-clinical studies on agomelatine.<h4>Method</h4>A MEDLINE, Psycinfo and Web of Science search (1966-May 2009) was performed using the following keywords: agomelatine, melatonin, S20098, efficacy, safety, adverse effect, pharmacokinetic, pharmacodynamic, major depressive disorder, bipolar disorder, Seasonal Affective Disorder (SAD), Alzheimer, ADHD, Generalized Anxiety Disorder (GAD), Panic Disorder (PD), Obsessive-C ...[more]

PMID: 21358978

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Project description:ObjectiveTo systematically review published and unpublished efficacy studies of agomelatine in people with depression.DesignSystematic review and meta-analysis.Data sourcesLiterature search (Pubmed, Embase, Medline), Cochrane Central Register of Controlled Trials, European Medicines Agency (EMA) regulatory file for agomelatine, manufacturers of agomelatine (Servier).Eligibility criteriaDouble blind randomised placebo and comparator controlled trials of agomelatine in depression with standard depression rating scales.Data synthesisStudies were pooled by using a random effects model with DerSimonian and Laird weights for comparisons with placebo and comparator antidepressant. The primary efficacy measure (change in rating scale score) was summarised with standardised mean difference (SMD; a measure of effect size) and secondary outcome measures with relative risks. All results were presented with 95% confidence intervals. Statistical heterogeneity was explored by visual inspection of funnel plots and by the I(2) statistic. Moderators of effect were explored by meta-regression.ResultsWe identified 20 trials with 7460 participants meeting inclusion criteria (11 in the published literature, four from the European Medicines Agency file, and five from the manufacturer). Almost all studies used the 17 item Hamilton depression rating scale (score 0-50). Agomelatine was significantly more effective than placebo with an effect size (SMD) of 0.24 (95% confidence interval 0.12 to 0.35) and relative risk of response 1.25 (1.11 to 1.4). Compared with other antidepressants, agomelatine showed equal efficacy (SMD 0.00, -0.09 to 0.10). Significant heterogeneity was uncovered in most analyses, though risk of bias was low. Published studies were more likely than unpublished studies to have results that suggested advantages for agomelatine.ConclusionsAgomelatine is an effective antidepressant with similar efficacy to standard antidepressants. Published trials generally had more favourable results than unpublished studies.

Project description:BackgroundThe therapeutic potential of subanesthetic doses of ketamine appears promising in unipolar depression; however, its effectiveness in treating bipolar depression (BD) remains uncertain.ObjectiveThis systematic review aimed to summarize findings on the use of ketamine for the treatment of BD by assessing its efficacy, safety, and tolerability.DesignSystematic review.MethodsWe conducted a systematic review of studies that investigated the use of ketamine for adults with BD. We searched PubMed and Embase for relevant randomized-controlled trials, open-label trials, and retrospective chart analyses published from inception to 13 March 2023.ResultsEight studies were identified [pooled n = 235; mean (SD) age: 45.55 (5.54)]. All participants who received intravenous (IV) ketamine were administered a dose of 0.5-0.75 mg/kg as an adjunctive treatment to a mood-stabilizing agent, whereas participants who received esketamine were administered a dosage ranging from 28 to 84 mg. Flexible dosing was used in real-world analyses. A total of 48% of participants receiving ketamine achieved a response (defined as ⩾50% reduction in baseline depression severity), whereas only 5% achieved a response with a placebo. Real-world studies demonstrated lower rates of response (30%) compared to the average across clinical trials (63%). Reductions in suicidal ideation were noted in some studies, although not all findings were statistically significant. Ketamine and esketamine were well tolerated in most participants; however, six participants (2% of the overall sample pool, 5 receiving ketamine) developed hypomanic/manic symptoms after infusions. Significant dissociative symptoms were observed at the 40-min mark in some trials.ConclusionPreliminary evidence suggests IV ketamine as being safe and effective for the treatment of BD. Future studies should focus on investigating the effects of repeated acute and maintenance infusions using a randomized study design.

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A systematic, updated review on the antidepressant agomelatine focusing on its melatonergic modulation.

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A systematic, updated review on the antidepressant agomelatine focusing on its melatonergic modulation.

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