A double-blind trial of fluoxetine, 20 mg, and placebo in out-patients with DSM-III-R major depression and melancholia.
As part of a study in which reduced rapid eye movement latency was used to predict treatment response, fluoxetine and placebo were compared in 89 outpatients with major depression with (n = 52) and without (n = 37) DSM-III-R melancholia, to determine whether the presence or absence of melancholia predicted antidepressant and/or placebo response. Following a 2-week, single-blind placebo lead-in, men and women were assigned by random allocation to double-blind fluoxetine, 20 mg/day, or placebo for 8 weeks. Fluoxetine was statistically significantly superior to placebo in patients with melancholia (endpoint change in the Montgomery-Asberg Depression Rating Scale [MADRS] score, response rates and remission rates). A weekly analysis demonstrated statistical superiority of fluoxetine compared with placebo at week 3 and continuing for the remainder of the study. Fluoxetine was statistically significantly more likely to reduce suicidal ideation compared with placebo, using the MADRS item 10 (suicidal ideation question).
Heiligenstein
J H
JH
Psychopharmacology Division, Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana 46285.
Tollefson
G D
GD
Faries
D E
DE
D000293:Adolescent; D000328:Adult; D000368:Aged; D001714:Bipolar Disorder / Q000145:classification / Q000188:drug therapy* / Q000523:psychology; D003866:Depressive Disorder / Q000145:classification / Q000188:drug therapy* / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005473:Fluoxetine / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome
D005473:Fluoxetine