Which Depressed Patients Respond to Nefazodone and When?
J Clin Psychiatry 2001;62:158-163
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Background: Retrospective data analyses were
conducted of a single-blind trial of 993 outpatients with
nonpsychotic major depression (DSM-III-R) treated for 12 weeks
with nefazodone to provide a more specific picture of the nature
and timing of response or remission to acute-phase treatment.
Method: All patients participated in a
single-blind, 16-week lead-in to obtain responders eligible for a
subsequent double-blind, randomized continuation phase trial.
Outcomes were defined by the 17-item Hamilton Rating Scale for
Depression (HAM-D). A >= 50% reduction from baseline defined
response, and a total HAM-D exit score of <= 8 defined
Results: Of all patients who entered the trial,
41.8% (last observation carried forward) responded at or before
week 4 (early responders), and an additional 25.2% responded
thereafter; 18.3% achieved remission at or before week 4; 33.6%
achieved remission after week 4. Thus, 77.3% of those responding
ultimately remitted. On average, remission followed response by 2
weeks. The average end-of-treatment dose was 376 mg/day at exit
(last observation carried forward). Responders or remitters (as
opposed to nonresponders or nonremitters) had lower baseline
depressive symptomatology and were more likely to be married or
Conclusion: The full symptomatic benefit of
antidepressant medication may not be apparent until completion of
an 8- to 10-week trial. A high number of responders ultimately
attained remission. Baseline demographic and clinical features
were not highly predictive of who would or would not benefit from
nefazodone. For routine care, a minimal acute-phase trial, using
a 50% reduction in baseline symptom severity to define response,
should be 8 weeks. Whether ultimate nonresponders can be
identified earlier than 8 weeks deserves further study.