A double-blind evaluation of zimelidine in comparison to placebo and amitmptyline in patients with major depressive disorder
| Autor: | Bernhard Huitfeldt, James Claghorn, Burton J. Goldstein, Stefan Behrnetz, Daniel F. Bush, Samuel Gershon |
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| Rok vydání: | 1983 |
| Předmět: |
Adult
Male Adolescent Side effect Pyridines Amitriptyline Placebo Double-Blind Method medicine Humans Biological Psychiatry Aged Zimelidine Psychiatric Status Rating Scales Pharmacology Depressive Disorder business.industry Zimeldine Middle Aged medicine.disease Brompheniramine Antidepressive Agents Clinical trial Clinical research Anesthesia Clinical Global Impression Major depressive disorder Female business medicine.drug |
| Zdroj: | Progress in Neuro-Psychopharmacology and Biological Psychiatry. 7:367-382 |
| ISSN: | 0278-5846 |
| DOI: | 10.1016/0278-5846(83)90125-2 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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