Paroxetine and Pediatric and Adolescent Clinical Trial Data

Paroxetine is not approved for the treatment of patients younger than 18 years of age. Please refer to the approved prescribing information for additional warnings and information.

GlaxoSmithKline has conducted a series of clinical studies to determine the efficacy and safety of paroxetine in treating children and adolescent patients with major depressive disorder, obsessive compulsive disorder and social anxiety disorder/social phobia. In the interest of further making the results of these studies available to all interested parties, GSK is posting to this Web page the following documents:

Clinical Study Reports

These are the formal study reports, which are the basis of submissions to the FDA, EMEA, MHRA and other regulatory agencies for all the studies of paroxetine in children and adolescents. They are presented here in two parts, the report Synopses, and the Full Reports (text and associated tables). [Because their size is many hundreds of pages, the appendices, which include line listings of raw data, the original protocol and its amendments, records of IRB approvals, etc., are not included. Names of investigators and sites have been redacted to preserve confidentiality.]

Bibliography of publications

This is a list of all the publications in peer-reviewed journals and poster presentations at scientific meetings which have been derived from
GSK-sponsored studies of paroxetine in adolescents and children.

Medical Information Letter

This letter is sent to healthcare professionals in the United States who request information about paroxetine and its use in children and/or adolescents.

2003 pediatric review

The document provides analyses of reports of suicide attempts and "possibly suicide-related" events from the pediatric-only clinical trials. Analyses look at two treatment periods from the placebo-controlled trials: (1) on-therapy (including taper phase); and (2) on-therapy plus 30 days post-therapy. The analyses also broke down events by indication.