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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.

journal_name

Biol Psychiatry

journal_title

Biological psychiatry

authors

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

doi

10.1016/s0006-3223(02)01971-6

subject

Has Abstract

pub_date

2003-10-15 00:00:00

pages

806-17

issue

eissn

0006-3223

issn

1873-2402

pii

S0006322302019716

journal_volume

pub_type

临床试验,杂志文章,随机对照试验

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