A DOUBLE-BLIND, COMPARATIVE, MULTICENTER STUDY COMPARING PAROXETINE WITH FLUOXETINE IN DEPRESSED-PATIENTS (REPRINTED FROM ACTA PSYCHIATR SCAND, VOL 87, PG 141-145, 1993)

A randomized, double-blind, parallel-group, 6-week study was undertake n to compare the efficacy and tolerability of once or twice daily admi nistration of the selective serotonin reuptake inhibitors paroxetine a nd fluoxetine. After a 1-week placebo wash-out, patients suffering fro m DSM-III major depression and with a score of 18 or more on the 21-it em Hamilton Rating Scale for Depression (HRSD) received either paroxet ine or fluoxetine. The patients were assessed for efficacy using the H RSD, Montgomery-Asberg Depression Rating Scale and Clinical Global Imp ression; for tolerability, adverse events were elicited by the use of a non-leading question and a side effects checklist. The groups of pat ients were comparable on entry to the study. one hundred patients were recruited into the study, of whom 78 were evaluable for the efficacy analysis. Paroxetine and fluoxetine showed comparable efficacy at the end of the 6-week treatment period, but a statistically significant di fference in the number of responders at week 3 in favour of paroxetine was observed. This could suggest an earlier onset of action with paro xetine. Also, associated anxiety symptoms were significantly reduced o n paroxetine compared with fluoxetine at week 3. Patients on paroxetin e reported fewer adverse events than those on fluoxetine. The most com monly reported adverse events were nausea and vomiting in both groups.