Paroxetine - paediatric and adolescent patients

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). Names of investigators and sites have been redacted to preserve confidentiality. Appendices to the reports are also included, consisting of tables of individual subject line listings of data, the study protocol, protocol amendments, and sample blank case report forms (CRFs), with redaction of personally-identifiable information where appropriate. Report appendices that consist of completed CRFs are not included here, as those appendices contain more extensive personally-identifiable information and the scientific data contained in those appendices is duplicated and available in the subject line listings of data that are posted here. GSK will consider requests for additional information from the reports that is required for a defined research question and methodology.

Clinical study reports are available to download in PDF format.

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.

Clinical study reports

Unipolar major depression study 329

Unipolar major depression study 377

Unipolar major depression 511

Major depressive disorder study 701

Major depressive disorder and obsessive-compulsive disorder study 716

Obsessive-compulsive disorder study 453

Obsessive-compulsive disorder study 704

Social anxiety disorder/social phobia study 676

Pharmacokinetics study 715

Other documents

Product information