[Efficacy and safety of fluoxetine versus clomipramine in ambulatory patients with a depressive syndrome in a clinical trial with private practitioners]

Abstract

8 general practitioners and 7 specialists in the field of psychiatry and neurology participated in this study evaluating the results of fluoxetine treatment in outpatients with depression in respect to safety and efficacy. They were familiarized with the requisite instruments by video rater training. The study was designed as a randomised double-blind parallel study involving 139 patients, comparing the effects of a daily dosage of 20 mg fluoxetine, 40 mg fluoxetine and 50 mg clomipramine. The number of patients treated in each group was 45, 46, and 48, respectively and altogether 125 completed the four-week study (five visits). A comparison of overall efficacy ratings showed significant antidepressant efficacy in all three treatment groups. On day 14 of the study (visit 4), patients receiving 40 mg fluoxetine showed significantly (p less than 0.05) better global improvement than patients receiving clomipramine. Treatment was well tolerated by all patients. The frequency of adverse events in response to fluoxetine was lower than under clomipramine treatment. On comparing treatment by psychiatrist and general practitioner no significant differences were found regarding age, sex, number of previous episodes and duration of the recent episode and outcome. Severe depression tended to be treated by psychiatrists; general practitioners prescribed additional medication less frequently.