Paroxetine in children with major depressive disorder: an open trial.

OBJECTIVE: To study the clinical benefits and safety of paroxetine (PXT) in a group of patients younger than 14 years old, with a diagnosis of major depressive disorder.

METHOD: Patients were recruited from a psychiatric outpatient clinic. They were assessed for disease severity using the Clinical Global Severity (CGS) scale at 1 month, 3 months, and 8 months. Intensity of the therapeutic response (the reduction in CGS) was measured after 1 and 3 months. All patients were given open-label treatment with PXT.

RESULTS: At the start of treatment, most patients had "severe" depression (mean CGS score, 3.02). This improved to a score of 2.2 after 1 month and to 1.22 after 3 months of treatment. All patients experienced a complete remission of symptoms by the end of treatment (mean 8.4 months). PXT was well tolerated. Only 4 of the 45 patients experienced (mainly gastrointestinal) side effects; in 3 patients the side effects were of mild severity, and none required withdrawal from the trial.

CONCLUSIONS: PXT can be effective in treating major depression and was well tolerated by children younger than 14 years old. This result indicates that PXT should be investigated further in children, in double-blind trials.