A double-blind, placebo-controlled trial of two dose ranges of nefazodone in the treatment of depressed outpatients.
BACKGROUND
Nefazodone hydrochloride, a 5-HT2 receptor antagonist that selectively inhibits serotonin reuptake, was evaluated in a double-blind, dose-finding study of novel design, involving 240 patients with major depression.


METHODS
Patients were randomly assigned to three treatment groups and received either placebo (2-6 capsules per day), a lower-dose range of nefazodone (50-300 mg/day), or a higher-dose range of nefazodone (100-600 mg/day) for 6 weeks.


RESULTS
At the end of treatment, the Hamilton Rating Scale for Depression and the clinician- and patient-rated Inventory for Depressive Symptomatology scores showed significant improvement (p < or = .05) for patients receiving higher-dose range nefazodone (mean = 392 mg/day) compared with placebo treatment. The percentage of responders (at least "much improved" on the Clinical Global Impressions-Improvement scale) in the higher-dose range nefazodone group (58%) was significantly greater (p < or = .05) than in the placebo group (39%). The treatment group receiving nefazodone in the lower-dose range was not differentiated in clinical response from placebo controls. The rate of discontinuation for adverse experience (14%) was similar for patients treated with higher-dose range nefazodone and placebo.


CONCLUSIONS
The findings of this study indicate that nefazodone is an effective and well-tolerated antidepressant drug, with a recommended therapeutic dose range of 100 to 600 mg/day and a starting dose of 100 mg b.i.d.
Mendels
J
J
Philadelphia Medical Institute, Pa., USA.
Reimherr
F
F
Marcus
R N
RN
Roberts
D L
DL
Francis
R J
RJ
Anton
S F
SF
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000553:Ambulatory Care; D000928:Antidepressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003866:Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010555:Personality Inventory; D010879:Piperazines; D010919:Placebos; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome; D014230:Triazoles / Q000008:administration & dosage / Q000627:therapeutic use*
D000928:Antidepressive Agents; D010879:Piperazines; D010919:Placebos; D014230:Triazoles; C051752:nefazodone