[Maintenance therapy with 20 mg fluoxetine. Results of an administration study of 1,737 depressed patients]. / Erhaltungstherapie mit 20 mg Fluoxetin. Ergebnis einer Anwendungsbeobachtung an 1737 depressiven Patienten/innen.

ABSTRACT

An application study was carried out in 1993/94 on the use of fluoxetine for the continuation therapy of depression. 1737 patients received fluoxetine at a dosage of 20 mg per day over a period of 6 months. Diagnosis was made by clinical evaluation of phenomenology and ICD-10 classification. Over the observation period physicians rated the course of illness according to severity of the depression, somatic complaints and therapeutic efficacy on a scale graded 1-4. Side effects and concomitant medication were also noted. Coincidentally, patients recorded subjective satisfaction with therapy, as well as side effects. In a subsample of 423 patients the physicians additionally used a modified version of the Hamilton Depression Rating Scale (HRDS) for behavioural ratings. Standard assessment was performed after the 2nd and 6th weeks of treatment and again after the 3rd and 6th months. The rating scale showed a decrease in depressive symptomatology and somatic complaints at the end of treatment in 53% and 44% of patients, respectively. Treatment efficacy was rated as excellent in 82% of cases, as evaluated by the physicians; patients were satisfied in 89% of cases. These results are strengthened by the reduction from 22.4 +/- 7.0 to 9.2 +/- 6.4 in the subsample of 423 patients according to the HRDS, equivalent to a decrease in depression symptomatology of 59%. This study is the first open phase IV trial in Austria investigating continuation therapy with 20 mg fluoxetine per day and confirms results obtained in international multicentre placebo-controlled studies involving considerably smaller numbers of patients.