A double-blind evaluation of zimelidine in comparison to placebo and amitmptyline in patients with major depressive disorder

James Claghorn, Samuel Gershon, Burton J. Goldstein, Stefan Behrnetz, Daniel F. Bush, Bernhard Huitfeldt

Research output: Contribution to journalArticle

26 Citations (Scopus)

Abstract

1. 1. This paper presents the results from a large multicenter study, performed at three clinical research units in the USA. Prior to a three to seven days of placebo washout period, patients were randomly assigned to zimelidine, a potent and selective 5-HT reuptake blocker, amitriptyline or placebo. The scheduled treatment period was four weeks. Dosage range was 75-300 mg/day for active medications. 2. 2. The rating instruments were the Hamilton Depression Scale and the Clinical Global Impression scale. The side effects were recorded by using a side effect inventory (TESS). Vital signs, laboratory work including clinical chemistry, ECG, and plasma levels of drugs, were performed. 3. 3. In the main efficacy evaluation there were 229 depressed outpatients included, all having completed at least two weeks of treatment after the washout period. The patients treated with zimelidine as well as those treated with amitriptyline showed a significant improvement relative to the placebo treated patients. 4. 4. For the safety evaluation 263 patients were included. Side effects, in particular antichollnergic effects but also drowsiness and cardiovascular effects, were much less pronounced in the zimelidine group as compared to the amitriptyline group. Only marginal differences regarding side effects were reported for zimelidine compared to those reported for placebo.

Original languageEnglish
Pages (from-to)367-382
Number of pages16
JournalProgress in Neuropsychopharmacology and Biological Psychiatry
Volume7
Issue number2-3
DOIs
StatePublished - Jan 1 1983
Externally publishedYes

Fingerprint

Zimeldine
Major Depressive Disorder
Amitriptyline
Placebos
Clinical Chemistry
Vital Signs
Sleep Stages
Multicenter Studies
Serotonin
Electrocardiography
Outpatients
Depression
Safety
Equipment and Supplies
Therapeutics
Research
Pharmaceutical Preparations

Keywords

  • amitriptyline
  • clinical trial
  • major depressive disorder
  • multicenter
  • placebo
  • zimelidine

ASJC Scopus subject areas

  • Biological Psychiatry
  • Pharmacology

Cite this

A double-blind evaluation of zimelidine in comparison to placebo and amitmptyline in patients with major depressive disorder. / Claghorn, James; Gershon, Samuel; Goldstein, Burton J.; Behrnetz, Stefan; Bush, Daniel F.; Huitfeldt, Bernhard.

In: Progress in Neuropsychopharmacology and Biological Psychiatry, Vol. 7, No. 2-3, 01.01.1983, p. 367-382.

Research output: Contribution to journalArticle

Claghorn, James ; Gershon, Samuel ; Goldstein, Burton J. ; Behrnetz, Stefan ; Bush, Daniel F. ; Huitfeldt, Bernhard. / A double-blind evaluation of zimelidine in comparison to placebo and amitmptyline in patients with major depressive disorder. In: Progress in Neuropsychopharmacology and Biological Psychiatry. 1983 ; Vol. 7, No. 2-3. pp. 367-382.
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