91896
document
A double-blind , placebo-controlled trial of nefazodone in the treatment of patients hospitalized for major depression . BACKGROUND There are few published placebo-controlled clinical trials demonstrating the efficacy of the newer antidepressants in markedly or severely depressed hospitalized patients . This study demonstrates the efficacy of nefazodone compared with placebo in the treatment of patients hospitalized for major depression . METHOD Nefazodone and placebo treatment were compared in a 6-week trial of 120 patients hospitalized for DSM-III-R diagnosed major depression ( without psychosis ) at 2 study centers . Efficacy was evaluated using standard psychiatric rating scales , and patients were monitored for safety . RESULTS Nefazodone treatment resulted in a significant reduction ( p < .01 ) of the 17-item Hamilton Rating Scale for Depression ( HAM-D-17 ) total score compared with placebo from the end of the first treatment week through the end of the study ( -12.2 nefazodone vs. -7.7 placebo ) . At the end of the trial , significantly more nefazodone-treated patients ( 50 % ) than placebo-treated patients ( 29 % ) had responded , as indicated by their Clinical Global Impressions-Improvement score ( p = .021 ) or by a > or = 50 % reduction in their HAM-D-17 scores ( p = .017 ) . Significantly more patients treated with nefazodone ( 36 % ) than placebo-treated patients ( 14 % ) had a HAM-D-17 score < or = 10 at the end of treatment ( p = .004 ) . Significant treatment differences ( p < .01 ) in favor of nefazodone were also seen in the Montgomery-Asberg Depression Rating Scale ; the HAM-D retardation , anxiety , and sleep disturbance factors ; and HAM-D item 1 ( depressed mood ) . Patients with dysthymia in addition to major depression also showed significant improvement ( p < .05 ) when treated with nefazodone , with significant differences in response rates seen as early as week 2 and through the end of the trial . The mean nefazodone dose was 491 mg/day at the end of week 2 and 503 mg/day at the end of treatment . Nefazodone was well tolerated , and the number of patients discontinuing owing to adverse events was small , with no significant safety issues noted in either treatment group . Fewer nefazodone-treated than placebo-treated patients discontinued owing to lack of efficacy . CONCLUSION Nefazodone was superior to placebo in the treatment of marked to severe major depression in patients requiring hospitalization . The clinical benefit of nefazodone was evident as early as the first week of treatment as judged by several measures of efficacy , with significant differences from placebo sustained throughout the trial .
91897
Intervention_Control
placebo-controlled
91898
Intervention_Pharmacological
nefazodone
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Intervention_Control
placebo-controlled
91900
Intervention_Pharmacological
nefazodone
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Intervention_Control
placebo
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Intervention_Pharmacological
Nefazodone
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Intervention_Control
placebo treatment
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Intervention_Control
placebo
91905
Intervention_Pharmacological
nefazodone
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Intervention_Control
placebo
91907
Intervention_Pharmacological
nefazodone-treated
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Intervention_Control
placebo-treated
91909
Intervention_Pharmacological
nefazodone
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Intervention_Control
placebo-treated
91911
Intervention_Pharmacological
nefazodone-treated
91912
Intervention_Control
placebo-treated
91913
Intervention_Pharmacological
Nefazodone
91914
Intervention_Pharmacological
nefazodone
91915
Outcome_Mental
standard psychiatric rating scales
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Outcome_Mental
17-item Hamilton Rating Scale for Depression
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Outcome_Other
Clinical Global Impressions-Improvement score
91918
Outcome_Mental
HAM-D-17 scores
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Outcome_Mental
HAM-D-17 score
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Outcome_Mental
Montgomery-Asberg Depression Rating Scale ; the HAM-D retardation , anxiety , and sleep disturbance factors ; and HAM-D item 1
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Outcome_Mental
dysthymia
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Outcome_Mental
major depression
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Outcome_Other
nefazodone
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Outcome_Other
well tolerated
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Outcome_Adverse-effects
adverse events
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Outcome_Other
efficacy
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Participant_Condition
major depression
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Participant_Condition
severely depressed
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Participant_Condition
major depression
91930
Participant_Condition
dysthymia
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Participant_Condition
major depression
91932
Participant_Condition
major depression