Nefazodone versus sertraline in outpatients with major depression: focus on efficacy, tolerability, and effects on sexual function and satisfaction.
BACKGROUND
The efficacy, tolerability, and effects on sexual function and satisfaction of nefazodone and sertraline were compared in a multicenter, randomized, double-blind, parallel-group study in outpatients with major depression.


METHODS
One hundred sixty patients, 18 years of age or older, who met DSM-III-R criteria for single or recurrent nonpsychotic major depressive episodes were randomly assigned to 6 weeks of treatment with either nefazodone (100-600 mg/day) or sertraline (50-200 mg/day). Symptoms were assessed before and during treatment using the 17-item Hamilton Rating Scale for Depression (HAM-D-17), Clinical Global Impressions (CGI) Improvement scale, the CGI Severity of Illness scale, and a sexual function questionnaire.


RESULTS
Of 143 patients evaluable for efficacy, 72 received sertraline and 71 received nefazodone. The mean modal daily dose at endpoint was 148 mg for sertraline and 456 mg for nefazodone. Analysis of efficacy measures (HAM-D-17 and CGI) showed consistent and comparable improvement in symptoms of depression for both treatment groups. Sertraline had negative effects on sexual function and satisfaction in both men and women, and nefazodone had no adverse effect on sexual well-being. Safety assessments based on adverse events, vital sign measurements, electrocardiographs, physical examinations, and clinical laboratory tests revealed no serious adverse events or organ toxicity associated with nefazodone or sertraline administration.


CONCLUSIONS
Nefazodone and sertraline are well tolerated, and there was no statistically significant difference in their antidepressant activity. Sertraline treatment has negative effects on sexual function and performance in both sexes, while nefazodone has none. These findings may have clinical implications when choosing antidepressant therapy.
Feiger
A
A
Feiger PsychMed Center, Wheat Ridge, Colo 80033, USA.
Kiev
A
A
Shrivastava
R K
RK
Wisselink
P G
PG
Wilcox
C S
CS
D015057:1-Naphthylamine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000553:Ambulatory Care; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D009948:Orgasm / Q000187:drug effects; D010879:Piperazines; D011569:Psychiatric Status Rating Scales; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D020280:Sertraline; D012720:Severity of Illness Index; D012725:Sexual Behavior / Q000187:drug effects*; D016896:Treatment Outcome; D014230:Triazoles / Q000009:adverse effects / Q000627:therapeutic use*
D015057:1-Naphthylamine; D018687:Antidepressive Agents, Second-Generation; D010879:Piperazines; D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline; D014230:Triazoles; C051752:nefazodone