title: Randomized, placebo-controlled trial of nefazodone maintenance treatment in preventing recurrence in chronic depression.
abstract: 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.
authors.affiliation: Department of Psychiatry, Health Sciences Center, University of Arizona, PO Box 245002, Tucson, AZ 85724-5002, USA.
authors.forename: Alan J
authors.initials: AJ
authors.lastname: Gelenberg
authors.forename: Madhukar H
authors.initials: MH
authors.lastname: Trivedi
authors.forename: A John
authors.initials: AJ
authors.lastname: Rush
authors.forename: Michael E
authors.initials: ME
authors.lastname: Thase
authors.forename: Robert
authors.initials: R
authors.lastname: Howland
authors.forename: Daniel N
authors.initials: DN
authors.lastname: Klein
authors.forename: Susan G
authors.initials: SG
authors.lastname: Kornstein
authors.forename: David L
authors.initials: DL
authors.lastname: Dunner
authors.forename: John C
authors.initials: JC
authors.lastname: Markowitz
authors.forename: Robert M A
authors.initials: RM
authors.lastname: Hirschfeld
authors.forename: Gabor I
authors.initials: GI
authors.lastname: Keitner
authors.forename: John
authors.initials: J
authors.lastname: Zajecka
authors.forename: James H
authors.initials: JH
authors.lastname: Kocsis
authors.forename: James M
authors.initials: JM
authors.lastname: Russell
authors.forename: Ivan
authors.initials: I
authors.lastname: Miller
authors.forename: Rachel
authors.initials: R
authors.lastname: Manber
authors.forename: Bruce
authors.initials: B
authors.lastname: Arnow
authors.forename: Barbara
authors.initials: B
authors.lastname: Rothbaum
authors.forename: Melvin
authors.initials: M
authors.lastname: Munsaka
authors.forename: Phillip
authors.initials: P
authors.lastname: Banks
authors.forename: Frances E
authors.initials: FE
authors.lastname: Borian
authors.forename: Martin B
authors.initials: MB
authors.lastname: Keller
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D003131:Combined Modality Therapy; D018592:Cross-Over Studies; D003865:Major Depressive Disorder / Q000517:prevention & control / Q000628:therapy*; D004311:Double-Blind Method; D004608:Eligibility Determination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010879:Piperazines; D011613:Psychotherapy / Q000379:methods*; D012008:Recurrence; D013375:Substance Withdrawal Syndrome / Q000453:epidemiology / Q000209:etiology; D014230:Triazoles / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D018687:Antidepressive Agents, Second-Generation; D010879:Piperazines; D014230:Triazoles; C051752:nefazodone