Antidepressant efficacy of sertraline: a double-blind, placebo- and amitriptyline-controlled, multicenter comparison study in outpatients with major depression

J Clin Psychiatry. 1990 Dec:51 Suppl B:18-27.


A double-blind, placebo- and amitriptyline-controlled comparison study was performed to evaluate the antidepressant efficacy of sertraline, a specific serotonin uptake inhibitor. Patients with DSM-III-defined major depression randomly received either sertraline (N = 149), amitriptyline (N = 149), or placebo (N = 150) once daily for the 8-week study period. The mean final daily medication dose for the all-patients group was 145 mg and 104 mg for the sertraline- and amitriptyline-treatment groups, respectively. As measured by the Hamilton Rating Scale for Depression and the Clinical Global Impressions Scale, both the sertraline and amitriptyline treatment groups showed a significantly greater improvement from baseline (p less than or equal to .001) than the placebo group. The sertraline group had a higher proportion of gastrointestinal complaints and male sexual dysfunction than either the amitriptyline or the placebo group. The amitriptyline group showed a higher proportion of anticholinergic and sedative side effects and dizziness compared with patients who received either sertraline or placebo.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • 1-Naphthylamine / analogs & derivatives*
  • 1-Naphthylamine / therapeutic use
  • Adolescent
  • Adult
  • Aged
  • Ambulatory Care*
  • Amitriptyline / adverse effects
  • Amitriptyline / therapeutic use
  • Depressive Disorder / drug therapy*
  • Depressive Disorder / psychology
  • Dizziness / chemically induced
  • Double-Blind Method
  • Female
  • Gastrointestinal Diseases / chemically induced
  • Humans
  • Male
  • Middle Aged
  • Placebos
  • Psychiatric Status Rating Scales
  • Serotonin Antagonists / therapeutic use*
  • Sertraline
  • Sexual Dysfunctions, Psychological / chemically induced


  • Placebos
  • Serotonin Antagonists
  • Amitriptyline
  • 1-Naphthylamine
  • Sertraline