The data: I found one study from which I could estimate the treatment estimate based on the abstract (Kennedy and Emsley, 2006). Here’s what the abstract said, in part: “The efficacy and safety of flexible dosing with the antidepressant agomelatine (25-50 mg/day) was evaluated in a 6-week, double-blind, randomized, placebo-controlled study involving 212 patients who met Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for major depressive disorder-current major depressive episode. Patients receiving agomelatine (25 mg and 50 mg/day) had a significantly lower mean Hamilton Rating Scale for Depression (HAM-D) score at endpoint compared with those who received placebo (14.1 +/- 7.7 vs. 16.5 +/- 7.4, p = 0.026)” Based on these means and standard deviations, I come up with an effect size of .31, which is considered small. A small effect does not make for “the ideal antidepressant.”
Duplicate Publication Watch: Read the abstracts from these two articles (Montgomery, 2006 and Kennedy and Emsley, 2006). I reproduced a segment from the Kennedy/Emsley abstract above and here’s a piece from
“In a recent placebo-controlled study, 212 MDD patients were randomly assigned double-blind to receive placebo or agomelatine 25 and 50 mg/day. There was a significant advantage for agomelatine after 6 weeks according to scores on the Hamilton Depression Rating Scale (HAM-D) (P = 0.026) and the Clinical Global Impression Severity (P = 0.017), with an improved response rate (P = 0.03).”
I have not seen the tolerability-related data, but I see not one shred of data to support “additional clinical benefits," unless he's referring to potential improvement in sleep. But if we're thinking of clinical benefits in the manner of better reduction of patient symptoms, there is simply no data to support that assertion. The "gap in the current therapeutic armamentarium" is that current treatments are not much more effective than placebo (as demonstrated by agomelatine), and they have notable side effects. When SSRIs and atypical antipsychotics emerged, they were considered to be much safer and better tolerated treatments than their predecessors and we now know that is not the case. Does this new “ideal” drug have a better safety profile? We had better wait and see before jumping on yet another bandwagon for a treatment that is overly hyped.
By the way, I tried to find more clinical trial data on this drug from the Novartis website, but their clinical trial register was not functional at the time.