The safety and efficacy of paroxetine compared with placebo in a double-blind trial of depressed outpatients.

Considerable research shows that serotonin dysfunction is implicated in major depression. Paroxetine is an investigational antidepressant that appears to act by selectively blocking neuronal serotonin uptake. Seventy-two outpatients with moderate-to-severe major depression entered this 6-week, double-blind comparison of paroxetine and placebo. The results showed clear and significant superiority of paroxetine on all of the major outcome variables. These included physician-rated measures such as the Hamilton Rating Scale for Depression and its four factor scores, the Clinical Global Impressions scale, the Montgomery and Asberg Depression Rating Scale, and the Raskin Depression Scale. Results on these agreed well with patient-rated measures like the Hopkins Symptom Checklist and Patient Global Evaluation Scale. Paroxetine was also very well tolerated. Nausea and constipation occurred significantly more often with paroxetine, but only 9% of paroxetine patients dropped out of the study due either in whole or in part to an adverse effect. This compares to 8% of the placebo patients who were discontinued for the same reason. This study suggests that paroxetine is a safe and effective medication for the treatment of major depression.

RCT Entities:   Population Interventions Outcomes