Serzone Clinical Trials and Studies

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Serzone Clinical Trials and Studies

Clinical Trials Supporting Effectiveness Claim

The efficacy of Serzone (nefazodone) as a treatment for depression was established in two placebo-controlled, short-term trials in outpatients meeting DSM-III or DSM-IIIR criteria for major depression. One was a 6-week dose-titration study comparing Serzone (nefazodone) in dose ranges (up to 300 mg/day and up to 600 mg/day [mean modal dose for this group was about 400 mg/day], on a b.i.d. schedule) and placebo. The other was an 8-week dose-titration study comparing nefazodone (up to 600 mg/day; mean modal dose was 375 mg/day), imipramine (up to 300 mg/day), and placebo, all on a b.i.d. schedule. Overall these studies demonstrated Serzone (nefazodone), at doses titrated up to 600 mg/day, to be superior to placebo on at least three of the four following measures: 17-item Hamilton Depression Rating Scale or HDRS (total score), Hamilton Depressed Mood item, CGI severity score, and CGI Improvement score. Significant differences were also found for certain factors of the HDRS (e.g., anxiety factor, sleep disturbance factor, and retardation factor). Two other 6-8 week placebo- and imipramine-controlled studies in depressed outpatients provided additional support for the superiority of Serzone (nefazodone) (titrated up to 500 or 600 mg/day; mean modal doses of 462 mg/day and 363 mg/day) over placebo.

There were no efficacy studies of Serzone (nefazodone) focusing specifically on the elderly or on men and women separately. Overall, approximately two-thirds of patients in these 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.

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