Placebo-controlled dose-ranging trial designs in phase II development of nefazodone.
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.
D'Amico
M F
MF
Bristol-Myers Squibb Company, CNS Clinical Research, Wallingford, CT 06492.
Roberts
D L
DL
Robinson
D S
DS
Schwiderski
U E
UE
Copp
J
J
D003866:Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D006801:Humans; D010879:Piperazines; D011569:Psychiatric Status Rating Scales; D016032:Randomized Controlled Trials as Topic; D012702:Serotonin Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D014230:Triazoles / Q000008:administration & dosage / Q000627:therapeutic use*
D010879:Piperazines; D012702:Serotonin Antagonists; D014230:Triazoles; C051752:nefazodone