Placebo-controlled dose-ranging trial designs in phase II development of nefazodone.

Abstract

Nefazodone is a selective 5-HT2 receptor antagonist. Nefazodone has a pharmacologic profile similar to trazodone and other phenylpiperazine antidepressants, but distinct from nonselective first-generation agents and other selectively acting second-generation agents. Results of a multicenter, double-blind, fixed-dose trial indicate nefazodone is effective in improving depressive symptoms of outpatients with major depressive disorder treated with daily doses of 100 mg to 200 mg. A comparison of the fixed-dose trial design with an alternative design permitting dose titration within fixed ranges is presented. The relative merits of each design for establishing therapeutic dose ranges are discussed.

• Authors: M F D'Amico, D L Roberts, D S Robinson, U E Schwiderski, J Copp
• Journal: Psychopharmacology bulletin (Psychopharmacol Bull) Vol. 26 Issue 1 Pg. 147-50 ( 1990) ISSN: 0048-5764 [Print] United States
• PMID: 2196622 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)

Chemical References

• Piperazines
• Serotonin Antagonists
• Triazoles
• nefazodone

Topics

• Depressive Disorder (drug therapy, psychology)
• Double-Blind Method
• Humans
• Piperazines
• Psychiatric Status Rating Scales
• Randomized Controlled Trials as Topic
• Serotonin Antagonists (administration & dosage, therapeutic use)
• Triazoles (administration & dosage, therapeutic use)