An open multicentre study to evaluate the efficacy and tolerance of fluoxetine 20 mg in depressed ambulatory patients.

In this study, 544 out-patients suffering from depressive disorders were enrolled in 6 weeks open study with fluoxetine 20 mg. A statistically significant decrease of the Hamilton Rating Scale for Depression (HRS-D) score is observed during treatment. All individual item HRS-D scores and in particular suicidal ideation, sleep disturbances and anxiety showed the same improvement. Side-effects were carefully recorded and presented a lower incidence rate than in other studies. New issues in methodology management concerning ambulatory studies are discussed.