Overall, approximately two thirds of patients in these trials were women, and an analysis of the effects of gender on outcome did not suggest any differential responsiveness on the basis of sex. There were too few elderly patients in these trials to reveal possible age-related differences in response.

Since its initial marketing as an antidepressant drug product, additional clinical investigations of SERZONE have been conducted. These studies explored SERZONEs use under conditions not evaluated fully at the time initial marketing approval was granted.

Two studies were conducted to evaluate SERZONEs effectiveness in hospitalized depressed patients. These were 6-week, dose-titration trials comparing SERZONE (up to 600 mg/day) and placebo, on a BID schedule. In one study, SERZONE was superior to placebo. In this study, the mean modal dose of SERZONE was 503 mg/day, and 85% of these inpatients were melancholic; at baseline, patients were distributed at the higher end of the 7-point CGI Severity scale, as follows: 4=moderately ill (17%); 5=markedly ill (48%); 6=severely ill (32%).In the other study, the differentiation in response rates between SERZONE and placebo was not statistically significant. This result may be explained by the "high" rate of spontaneous improvement among the patients randomized to placebo.

Two studies were conducted to assess SERZONEs capacity to maintain a clinical remission in acutely depressed patients who were judged to have responded adequately (HDRS total score ≤10) after a 16-week period of open treatment with SERZONE (titration up to 600 mg/day).In one study, SERZONE was superior to placebo. In this study, patients (n=131) were randomized to continuation on SERZONE or placebo for an additional 36 weeks (1 year total). This study demonstrated a significantly lower relapse rate (HDRS total score ≥18) for patients taking SERZONE compared to those on placebo. The second study was of appropriate design and power, but the sample of patients admitted for evaluation did not suffer relapses at a high enough incidence to provide a meaningful test of SERZONEs efficacy for this use.

Highly variable results have been seen in the clinical development of all antidepressant drugs. Furthermore,in those circumstances when the drugs have not been studied in the same controlled clinical trial(s),comparisons among the findings of studies evaluating the effectiveness of different antidepressant drug products are inherently unreliable. Because conditions of testing (eg, patient samples, investigators, doses of the treatments administered and compared, outcome measures, etc) vary among trials, it is virtually impossible to distinguish a difference in drug effect from a difference due to one or more of the confounding factors just enumerated.

Bookmark this page: