A study in International Clinical Psychopharmacology compared three doses of agomelatine to paroxetine (Paxil or Seroxat) and placebo in the treatment of depression. I will write about the efficacy of agomelatine soon, but this post focuses on the alleged safety of the medications.
In the abstract, the authors wrote, “Agomelatine, whatever the dose, showed good acceptability with a side-effect profile close to that of placebo.” In the discussion, they state “Agomelatine is very well tolerated with an adverse event profile close to placebo.”
Now we are going to compare the rate of suicide and suicide attempts on medication to the rate of suicides and suicide attempts on placebo. Here is the data from the study, which is quoted directly (with added emphases):
During the study, two participants committed suicide, one [of 147 patients] on paroxetine after 11 days of treatment, one [of 137 patients] on agomelatine 25 mg of treatment after 10 days of treatment (both deaths being unrelated to treatment according to the investigator's opinion)... There were seven suicide attempts, one [of 141 patients] on agomelatine 1mg, three [of 147 patients] on agomelatine 5 mg, one on agomelatine 25 mg, two on paroxetine and none [of 139 patients] on placebo (p. 244).
Suicide and suicide attempts are never mentioned again in the article. Imagine that the data went the other direction – that there were suicide attempts and actual suicides on placebo, but not on medication. In such a case, there would almost certainly be further discussion of how the medication seemed to offer a protective effect against suicide. I give the authors credit for at least presenting the relevant data, but it is quite odd that the data on such a serious matter were simply brushed away.
This reminded me a bit of the Paxil/Seroxat study #329, in which suicide attempts were much more common on drug than placebo, but the study investigators deemed that none of these serious events were related to the medication. Same old story: The drugs don’t cause suicidal ideation and actual suicide – only depression can do that. Does Traci Johnson ring a bell for anyone?