Safety and efficacy of bupropion, a novel antidepressant

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Bupropion, a pharmacologically unique antidepressant, was found to be both safe and effective in an open clinical trial in 16 depressed inpatients. Subjects were given either bupropion in doses ranging from 300 to 750 mg daily or the positive control amitriptyline in doses ranging from 75–300 mg daily. Patients were dosed following an ascending dosage regimen for a minimum of 2 and up to 10 weeks. Clinical assessment of antidepressant efficay was made prior to, during, and on the last day of drug therapy through the use of the Hamilton depression scale, the Zung self‐rating depression scale, and the clinical global impressions rating scale. Patients were assessed for adverse reactions on relevant observational, medical, and clinical laboratory tests prior to and throughout the study. Patients improved significantly from baseline on the efficacy rating scales in a manner similar to the positive control, though the small size of the positive control group lessened the chance of occurrence of statistically significant differences between groups. The main adverse reactions reported by bupropion‐treated patients were agitation or excitement, insomnia, and a mild tremor. Dry mouth and orthostatic hypotension occurred most often in amitriptyline‐treated patients. Copyright © 1985 Alan R. Liss, Inc.

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Drug Development Research