A double-blind trial of fluoxetine, 20 mg, and placebo in out-patients with DSM-III-R major depression and melancholia.

Abstract

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).

• Authors: J H Heiligenstein, G D Tollefson, D E Faries
• Journal: International clinical psychopharmacology (Int Clin Psychopharmacol) Vol. 8 Issue 4 Pg. 247-51 ( 1993) ISSN: 0268-1315 [Print] England
• PMID: 8277143 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)

Chemical References

• Fluoxetine

Topics

• Adolescent
• Adult
• Aged
• Bipolar Disorder (classification, drug therapy, psychology)
• Depressive Disorder (classification, drug therapy, psychology)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Fluoxetine (administration & dosage, adverse effects)
• Humans
• Male
• Middle Aged
• Psychiatric Status Rating Scales
• Treatment Outcome