RESPONDERS TO ANTIDEPRESSANT DRUG-TREATMENT - A STUDY COMPARING NEFAZODONE, IMIPRAMINE, AND PLACEBO IN PATIENTS WITH MAJOR DEPRESSION

Background: Nefazodone hydrochloride, an antidepressant that acts as a 5-HT2 antagonist and serotonin (5-HT) and norepinephrine uptake inhib itor, was evaluated in a double-blind, imipramine- and placebo-control led study involving 128 patients with major depression. Method: Eligib le patients were randomly assigned to receive placebo (2 to 6 capsules /day), imipramine (100 to 300 mg/day), or nefazodone (200 to 600 mg/da y) for 8 weeks. The principal efficacy outcome measure assessed was th e number of patients who experienced an adequate response during treat ment. Results: Based on global improvement (Clinical Global Impression s-Improvement). 67% of nefazodone-treated patients (p less than or equ al to .01) and 63% of imipramine-treated patients (p less than or equa l to .05) responded during 8 weeks of treatment, compared with 36% of placebo controls. Sixty-two percent of nefazodone-treated, 53% of imip ramine-treated, and 26% of placebo-treated patients had 17-item Hamilt on Rating Scale for Depression (HAM-D-17) scores less than or equal to 10 on completion of acute treatment. Nefazodone-treated patients had a lower incidence of premature treatment discontinuation and fewer dro pouts for adverse events than the imipramine group. Conclusion: In a t hree-arm comparison with imipramine and placebo, nefazodone had the gr eatest number of patients with major depression who responded to thera py. Nefazodone, a new antidepressant with novel pharmacology, is a wel l-tolerated, efficacious antidepressant.