Double-blind, multicenter comparative study of sertraline and amitriptyline in hospitalized patients with major depression

H. J. Möller, J. Gallinat, U. Hegerl, M. Arató, Z. Janka, B. Pflug, H. Bauer

Research output: Contribution to journalArticle

29 Citations (Scopus)

Abstract

Sertraline is a selective serotonin reuptake inhibitor (SSRI) for which marketing approval has been obtained recently in Germany. The results of several double-blind, placebo-controlled studies have demonstrated that sertraline has a clear antidepressive effect. However these studies have been conducted in outpatient populations. In the context of this multicenter study, a total of 160 inpatients were treated with sertraline 50-150 mg or amitriptyline 75-225 mg over a period of 6 weeks in a double-blind fashion. Sixty-two patients in the sertraline and 59 patients in the amitriptyline group were evaluated for efficacy in the according-to-protocol (ATP) population; 80 sertraline and 75 amitriptyline patients were evaluated for safety in the Intention-to-treat population (ITT). No statistically significant differences were detected between the two groups in the efficacy analysis performed on the basis of the Hamilton Depression Scale (HAM-D) total score and Clinical Global Impression (CGI). Due to its sedating properties, amitriptyline was found to be significantly more effective with regard to the HAM-D factor 'sleep disturbance'. The safety analysis, which was based on the CGI, the global assessment at the end of study and a score for somatic adverse events (FSUCL) revealed statistically significant advantages of sertraline over amitriptyline. Amitriptyline was associated with more autonomic and circulatory side effects, while epigastric complaints occurred more often with sertraline. The incidence of nausea - a typical SSRI side effect - was the same in both groups.

Original languageEnglish
Pages (from-to)170-177
Number of pages8
JournalPharmacopsychiatry
Volume31
Issue number5
Publication statusPublished - 1998

Fingerprint

Sertraline
Amitriptyline
Multicenter Studies
Depression
Serotonin Uptake Inhibitors
Population
Safety
Marketing
Nausea
Germany
Inpatients
Sleep
Outpatients
Placebos
Incidence

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Psychiatry and Mental health
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

Möller, H. J., Gallinat, J., Hegerl, U., Arató, M., Janka, Z., Pflug, B., & Bauer, H. (1998). Double-blind, multicenter comparative study of sertraline and amitriptyline in hospitalized patients with major depression. Pharmacopsychiatry, 31(5), 170-177.

Double-blind, multicenter comparative study of sertraline and amitriptyline in hospitalized patients with major depression. / Möller, H. J.; Gallinat, J.; Hegerl, U.; Arató, M.; Janka, Z.; Pflug, B.; Bauer, H.

In: Pharmacopsychiatry, Vol. 31, No. 5, 1998, p. 170-177.

Research output: Contribution to journalArticle

Möller, HJ, Gallinat, J, Hegerl, U, Arató, M, Janka, Z, Pflug, B & Bauer, H 1998, 'Double-blind, multicenter comparative study of sertraline and amitriptyline in hospitalized patients with major depression', Pharmacopsychiatry, vol. 31, no. 5, pp. 170-177.
Möller, H. J. ; Gallinat, J. ; Hegerl, U. ; Arató, M. ; Janka, Z. ; Pflug, B. ; Bauer, H. / Double-blind, multicenter comparative study of sertraline and amitriptyline in hospitalized patients with major depression. In: Pharmacopsychiatry. 1998 ; Vol. 31, No. 5. pp. 170-177.
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