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

ABSTRACT:

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.

Setting

12 North American academic psychiatry centres, from 20 April 1994 to 15 February 1998.

Participants

275 adolescents with major depression of at least eight weeks in durat

SUBMITTER: Le Noury J 

PROVIDER: S-EPMC4572084 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature