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  • Title: A double-blind, placebo-controlled trial of two dose ranges of nefazodone in the treatment of depressed outpatients.
    Author: Mendels J, Reimherr F, Marcus RN, Roberts DL, Francis RJ, Anton SF.
    Journal: J Clin Psychiatry; 1995; 56 Suppl 6():30-6. PubMed ID: 7649971.
    Abstract:
    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. METHOD: 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. CONCLUSION: 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.
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