Predictors of the placebo response in a nutraceutical randomized controlled trial for depression

作     者：Rosemary Arnold Jenifer Murphy-Smith Chee H.Ng David Mischoulon Gerard J.Byrne Chad A.Bousman Con Stough Michael Berk Jerome Sarris Rosemary Arnold;Jenifer Murphy-Smith;Chee H.Ng;David Mischoulon;Gerard J.Byrne;Chad A.Bousman;Con Stough;Michael Berk;Jerome Sarris

作者机构：Professorial Unitthe Melbourne ClinicDepartment of PsychiatryUniversity of MelbourneRichmond 3121Australia Depression Clinical and Research ProgramDepartment of PsychiatryMassachusetts General HospitalHarvard Medical SchoolBostonMA 02115USA Faculty of MedicineDiscipline of PsychiatryCentre for Clinical ResearchRoyal Brisbane&Women’s HospitalHerstonthe University of QueenslandBrisbane 4006Australia Departments of Medical GeneticsPsychiatryPhysiology&Pharmacology and Community Health SciencesUniversity of CalgaryCalgaryAB T2N 1N4Canada Department of Psychiatrythe University of MelbourneMelbourne 3052Australia Centre for Human PsychopharmacologySwinburne UniversityMelbourne 3122Australia The Institute for Mental and Physical Health and Clinical TranslationSchool of MedicineBarwon HealthDeakin UniversityGeelong 3220Australia The Centre of Excellence in Youth Mental Healththe University of MelbourneParkville 3052Australia Florey Institute of Neuroscience and Mental Healththe University of MelbourneParkville 3052Australia NICM Health Research InstituteWestern Sydney UniversityWestmeadNSW 2145Australia 

出 版 物：《Journal of Integrative Medicine》 (结合医学学报（英文版）)

年 卷 期：2024年第22卷第1期

页      面：46-53页

核心收录：

学科分类：1002[医学-临床医学] 100205[医学-精神病与精神卫生学] 10[医学] 

基　　金：funded by an Australian National Health and Medical Research Council project grant (No. APP1048222) and was co-sponsored by FITBio Ceuticals (who provided the trial product and placebo) supported by an NHMRC Fellowship (No. APP1125000) supported by a NHMRC Senior Principal Research Fellowship (No. 1059660 and 1156072) 

主　　题：Randomized controlled trial Placebo Depression Nutraceutical Psychiatry 

摘      要：Objective The placebo response in depression studies is the change in symptoms amongst those who receive an inactive *** well-designed randomized controlled trials(RCTs)of depression have a high proportion of placebo responders,with little understanding as to *** present study assesses characteristics associated with the placebo response in a nutraceutical trial with a large proportion of placebo *** This is a secondary analysis of a nutraceutical depression RCT which identified no overall treatment benefit relative to placebo(n=69 in placebo group).We investigated participant characteristics such as socio-demographics,clinical features,and recruitment methods,and their association with the placebo *** genetic polymorphisms were also *** response was measured based on change in Montgomery-Asberg Depression Rating Scale *** association of these hypothesis-driven variables of interest and the placebo response was examined using linear mixed effects *** Greater levels of education,particularly pursuing post-high school education,better self-reported general health,marriage/de facto,greater improvement in the first trial week,and more failed antidepressant therapies in the current depressive episode were associated with greater placebo *** increased placebo response was not found in those recruited via social media nor in those with concomitant antidepressant *** nucleotide polymorphisms from the tryptophan hydroxylase 1(TPH1)gene(A779C and A218C)were weakly associated with greater placebo response,although the evidence was attenuated after accounting for multiple *** This is,to our knowledge,the first study within nutraceutical research for depression to assess the association between participant characteristics and variation in the placebo *** variables appeared to predict the placebo *** findings may encourage future trial design