Medicina Bucureşti

The Lancet, Volume 379, Issue 9812, Page 215, 21 January 2012

Novel melatonin-based treatments for major depression

Ian Hickie and Naomi Rogers, in their review of the pharmacology and clinical profile of novel melatonin-based therapies (Aug 13, p 621),1 report that agomelatine has clinically significant antidepressant properties. However, this claim is not based on a systematic review of available evidence nor supported by the efficacy data that Hickie and Rogers themselves present.
A reanalysis of the efficacy of agomelatine versus placebo, by application of standard Cochrane methods to the data reported in Hickie and Rogers's table 3, reveals that acute treatment with agomelatine 50 mg is associated with a difference over placebo of 1·5 points on the Hamilton scale (figure). No research evidence or consensus is available about what constitutes a clinically meaningful difference in Hamilton scores, but, as reported by some authors of agomelatine clinical trials,2 a difference of less than 3 points seems unlikely to be regarded as such. In terms of comparative efficacy, agomelatine is not better than fluoxetine (three trials, mean difference 0·08, 95% CI −1·80 to 1·95, I2=73%) and is probably worse than paroxetine (four trials, standardised mean difference 0·18 in favour of paroxetine, 95% CI −0·02 to 0·38, I2=63%).

In terms of tolerability, Hickie and Rogers do not mention the potential relation between agomelatine and hepatic problems.3 For long-term data, they included three studies, two negative and one positive comparison between agomelatine and placebo, but in the text of the article and in the summary only the positive study is mentioned.
We argue that any reporting of clinical trial data, even in review articles that are focused on new biological mechanisms, should follow the same standard of reporting that is required from authors of systematic reviews.
We declare that we have no conflicts of interest.

References
1 Hickie IB, Rogers NL. Novel melatonin-based therapies: potential advances in the treatment of major depression. Lancet 2011; 378: 621-631. Summary | Full Text | PDF(215KB) | CrossRef | PubMed
2 Stahl SM, Fava M, Trivedi MH, Caputo A, Shah A, Post A. Agomelatine in the treatment of major depressive disorder: an 8-week, multicenter, randomized, placebo-controlled trial. J Clin Psychiatry 2010; 71: 616-626. CrossRef | PubMed
3 European Medicines Agency. CHMP assessment report for Valdoxan. http://www.ema.europa.eu/docs/en_GB/doc ... 046226.pdf. (accessed Dec 16, 2011).

http://www.thelancet.com/journals/lance ... a3=segment

tu ce specialitate onorezi cu prezenta, jerom? daca mi se permite intrebarea

eu pana acum nu am avut pacienti carora sa le mearga mai bine cu agomelatin. in primele zile dorm ceva mai bine, dar atat.

Idem şi la mine. Dar poate agomelatina asta nu e suficient de veche ca să aibă propria mitologie, ca prozacu.

Normal ar fi fost sa compare agomelatine cu Prozac, nu cu placebo. Singurul studiu in care au facut-o are o problema pentru ca Prozacul nu e diferit de placebo iar agomelatine de ambele. Dar probabil in studiul asta si-au exclus pacientii cu depresie severa (sau procentajul lor nu e suficient de mare ca sa arate o diferenta) in care Prozacu s-a dovedit ca merge si astfel au evitat sa fie inferiori prozacului...ar fi interesant de comparat prozacu cu agomelatine in subpopulatia de severi. poate asa il convingem pe vlad ca nu intotdeauna prozacul e mit:P

Nici nu cred că e mit, serios. E un medicament f mișto. În schimb, deși știu că experiența personală nu ar trebui să fie relevantă pt practică decât undeva la coadă, după studii, eu n-am observat niciun efect, de niciun fel, la agomelatina asta.

Pai da, si studiile alea arata cam acelasi lucru.