Randomized, placebo-controlled trial of nefazodone maintenance treatment in preventing recurrence in chronic depression.

Journal Article (Clinical Trial;Journal Article)

BACKGROUND: Maintenance treatment to prevent recurrences is recommended for chronic forms of major depressive disorder (MDD), but few studies have examined maintenance efficacy of antidepressants with chronic MDD. This randomized, placebo-controlled study of the efficacy and safety of nefazodone in preventing recurrence was conducted for patients with chronic MDD. METHODS: A total of 165 outpatients with chronic, nonpsychotic MDD, MDD plus dysthymic disorder ("double-depression"), or recurrent MDD with incomplete inter-episode recovery, who achieved and maintained a clinical response during acute and continuation treatment with either nefazodone alone or nefazodone combined with psychotherapy, were randomized to 52 weeks of double-blind nefazodone (maximum dose 600 mg/day) or placebo. The occurrence of major depressive episodes during maintenance treatment was assessed with the 24-item Hamilton Rating Scale for Depression, a DSM-IV MDD checklist, and a blinded review of symptom exacerbations by a consensus committee of research clinicians. RESULTS: Application of a competing-risk model that estimated the conditional probability of recurrence among those patients remaining on active therapy revealed a significant (p =.043) difference between nefazodone (n = 76) and placebo (n = 74) when the latter part of the 1-year maintenance period was emphasized. At the end of 1 year, the conditional probability of recurrence was 30.3% for nefazodone-treated patients, compared with 47.5% for placebo-treated patients. Prior concomitant psychotherapy during acute/continuation treatment, although enhancing the initial response, was not associated with lower recurrence rates. Discontinuations due to adverse events were relatively low for both nefazodone (5.3%) and placebo (4.8%). Somnolence was significantly greater among the patients taking active medication (15.4%), compared with placebo (4.6%). CONCLUSIONS: Nefazodone is well-tolerated and is an effective maintenance therapy for chronic forms of MDD.

Full Text

Duke Authors

Cited Authors

  • Gelenberg, AJ; Trivedi, MH; Rush, AJ; Thase, ME; Howland, R; Klein, DN; Kornstein, SG; Dunner, DL; Markowitz, JC; Hirschfeld, RMA; Keitner, GI; Zajecka, J; Kocsis, JH; Russell, JM; Miller, I; Manber, R; Arnow, B; Rothbaum, B; Munsaka, M; Banks, P; Borian, FE; Keller, MB

Published Date

  • October 15, 2003

Published In

Volume / Issue

  • 54 / 8

Start / End Page

  • 806 - 817

PubMed ID

  • 14550680

International Standard Serial Number (ISSN)

  • 0006-3223

Digital Object Identifier (DOI)

  • 10.1016/s0006-3223(02)01971-6

Language

  • eng

Conference Location

  • United States