Double-blind, placebo-substitution study of nefazodone in the prevention of relapse during continuation treatment of outpatients with major depression

The efficacy of nefazodone in prevention of relapse of depression was evalu ated in a 36-week double-blind, placebo-substitution, continuation treatmen t trial. After 16 weeks of acute, single-blind treatment with nefazodone, 1 31 patients responding to treatment and in stable remission were randomized in a 36-week double-blind trial to either nefazodone (n = 65) or placebo ( n = 66). Patients were defined as having relapsed if they had a total score greater than or equal to 18 on the 17-item Hamilton Depression Scale on tw o consecutive visits or if they discontinued treatment for lack of efficacy . Relapse rates were significantly lower for patients randomized to continu ed nefazodone treatment than for patients switched to placebo. Kaplan-Meier estimates of relapse rates 9 months (36 weeks) after the end of acute trea tment were 1.8% for nefazodone versus 18.3% for placebo (P = 0.009) by the Hamilton Depression Scale and 17.3% versus 32.8% (P = 0.028) by discontinua tion for lack of efficacy. The mean modal dose of nefazodone was 412 mg/day at study endpoint. These results demonstrate the clinical effectiveness of up to 1 year's treatment (16 weeks acute and 36 weeks continuation) with n efazodone in depressed patients. Long-term efficacy of nefazodone was accom panied by a good safety profile without any weight gain and with minimal sy mptoms of withdrawal upon abrupt discontinuation of treatment. Int Clin Psy chopharmacol 14:19-28 (C) 1999 Lippincott Williams & Wilkins.