Does the presence of an open-label antidepressant treatment period influence study outcome in clinical trials examining augmentation/combination strategies in treatment partial responders/nonresponders with major depressive disorder?

The Journal of Clinical Psychiatry
Nadia Iovieno, George I Papakostas

Abstract

The authors sought to determine study design factors that may influence clinical trial outcome in augmentation/combination trials for antidepressant partial responders/nonresponders with major depressive disorder (MDD) and to examine whether the use of a prospective treatment phase (lead-in) to assess antidepressant nonresponse may result in a better chance to detect a drug-placebo separation in such trials. MEDLINE/PubMed publication databases were searched for randomized, double-blind, placebo-controlled trials of adjunctive pharmacologic strategies for antidepressant partial responders/nonresponders with MDD. The search term depression was successively cross-referenced with the terms augmentation, adjunct, and adjunctive to identify pertinent trials. (The search was limited to articles published between January 1980 and October 2010.) Thirty-five articles involving 40 adjunctive drug versus placebo comparisons were pooled (n = 4,676). Final inclusion of articles was determined by consensus between the authors. Data extracted included whether there was a lead-in phase and, if so, the drugs, the doses, and the total duration of the lead-in phase. Additional data extracted included the number of patients enrolled, patient chara...Continue Reading

Citations

Mar 2, 2013·Nature Reviews. Drug Discovery·Paul EnckWinfried Rief
Jan 16, 2016·Annals of the New York Academy of Sciences·Antony LoebelAndrei Pikalov
May 21, 2014·European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology·Michele FornaroPantaleo Fornaro
Apr 23, 2014·Journal of Affective Disorders·Romain IcickJean-Pierre Lépine
Oct 21, 2014·PloS One·Selver Demic, Sen Cheng
Aug 21, 2013·Journal of Affective Disorders·Sakina J RizviSidney H Kennedy
May 17, 2015·Contemporary Clinical Trials·Joanna Moncrieff, Irving Kirsch
Apr 17, 2012·Progress in Neuro-psychopharmacology & Biological Psychiatry·Takeshi InoueTsukasa Koyama
Jan 29, 2020·Molecular Psychiatry·Naji C SalloumGeorge I Papakostas

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