Placebo Response in Antipsychotic Clinical Trials

作者：Bret R. Rutherford, Emily Pott, Jane M. Tandler, Melanie M. Wall, Steven P. Roose, Jeffrey A. Lieberman · 发表于：JAMA Psychiatry · 年份：2014 · DOI：10.1001/jamapsychiatry.2014.1319 · 被引用次数：149 · 研究领域：Schizophrenia research and treatment、Pain Management and Placebo Effect、Treatment of Major Depression

IMPORTANCE: Because increasing placebo response rates decrease drug-placebo differences and increase the number of failed trials, it is imperative to determine what is causing this trend. OBJECTIVES: To investigate the relationship between antipsychotic medication and placebo response by publication year, and to identify associated study design and implementation variables. DATA SOURCES: MEDLINE, PsycINFO, and PubMed were searched to identify randomized clinical trials of antipsychotic medications published from 1960 to July 2013. STUDY SELECTION: Included were randomized clinical trials lasting 4 to 24 weeks, contrasting antipsychotic medication with placebo or an active comparator, and enrolling patients 18 years of age or older with schizophrenia or schizoaffective disorder. DATA EXTRACTION AND SYNTHESIS: Standardized mean change scores were calculated for each treatment arm, plotted against publication year, and tested with Spearman rank correlation coefficients. Hierarchical linear modeling identified factors associated with the standardized mean change across medication and placebo treatment arms. MAIN OUTCOMES AND MEASURES: We hypothesized that the mean change in placebo-treated patients would significantly increase from 1960 to the present, that a greater change would be observed in active comparator vs placebo-controlled trials, and that more protocol visits would increase the symptom change observed. RESULTS: In the 105 trials examined, the mean change observed in p...