Study 329 continuation phase: Safety and efficacy of paroxetine and imipramine in extended treatment of adolescent major depression.

Objective: This is an analysis of the unpublished continuation phase of Study 329, the primary objective of which was to compare the efficacy and safety of paroxetine and imipramine with placebo in the treatment of adolescents with unipolar major depression. The objectives of the continuation phase were to assess safety and relapse rates in the longer term. The objective of this publication, under the Restoring Invisible and Abandoned Trials (RIAT) initiative, was to see whether access to and analysis of the previously unpublished dataset from the continuation phase of this randomized controlled trial would have clinically relevant implications for evidence-based medicine.

Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence.

Objectives: To reanalyse SmithKline Beecham's Study 329 (published by Keller and colleagues in 2001), the primary objective of which was to compare the efficacy and safety of paroxetine and imipramine with placebo in the treatment of adolescents with unipolar major depression. The reanalysis under the restoring invisible and abandoned trials (RIAT) initiative was done to see whether access to and reanalysis of a full dataset from a randomised controlled trial would have clinically relevant implications for evidence based medicine.

Design: Double blind randomised placebo controlled trial.

ICD-11 should not repeat the mistakes made by DSM-5.

Having two systems of psychiatric diagnosis creates unnecessary confusion therefore it would be desirable to achieve increased consistency between ICD-11 and DSM-5. Unfortunately, however, DSM-5 has included many controversial suggestions that have weak scientific support and insufficient risk-benefit analysis. As a result ICD-11 should learn from the DSM-5 mistakes rather than repeating them.