Joanna Le Noury, research psychologist1,
John M Nardo, retired clinical assistant professor2,
David Healy, professor1,
Jon Jureidini, clinical professor3,
Melissa Raven, postdoctoral fellow3,
Catalin Tufanaru, research associate4,
Elia Abi-Jaoude, staff psychiatrist5
Author affiliations
Correspondence to: J Jureidini Jon.Jureidini@adelaide.edu.au
Accepted 3 August 2015
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 duration. Exclusion criteria included a range of comorbid psychiatric and medical disorders and suicidality.
Interventions Participants were randomised to eight weeks double blind treatment with paroxetine (20-40 mg), imipramine (200-300 mg), or placebo.
Main outcome measures The prespecified primary efficacy variables were change from… Leer más...
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