Analyzing the Placebo Response and Identifying Influential Factors in Oral Medication Trials for Acute-Phase Schizophrenia.

Background and Hypothesis This study aims to develop a placebo response and dropout rate model for acute-phase schizophrenia medication trials and assess factors affecting this response to inform future trial design. Study Design We conducted a literature update using a comprehensive meta-analysis o...

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Publicado en:Schizophrenia Bulletin Vol. 52; no. 1; pp. 1 - 12
Autores principales: Ren, Jiyuan, Zhang, Lei, Xu, Ling, Lv, Yinghua, Huang, Jihan, Feng, Yulin, Guo, Haoyang, Wang, Yexuan, Yang, Juan, Zheng, Qingshan
Formato: equations & formulas meta analysis research tables/charts Journal Article
Publicado: Oxford University Press / USA Jan2026
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Jan2026
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      pub: Oxford University Press / USA
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        atl: Analyzing the Placebo Response and Identifying Influential Factors in Oral Medication Trials for Acute-Phase Schizophrenia.
      aug:
        au:
          Ren, Jiyuan
          Zhang, Lei
          Xu, Ling
          Lv, Yinghua
          Huang, Jihan
          Feng, Yulin
          Guo, Haoyang
          Wang, Yexuan
          Yang, Juan
          Zheng, Qingshan
        affil: Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, China
      sug:
        subj:
          Schizophrenia
          Administration, Oral
          Clinical Trials
          Research Subjects Psychosocial Factors
          Research Dropouts Evaluation
          Prediction Models Evaluation
          Human
          Adult
          Middle Age
          Male
          Female
          Meta Analysis
          Funding Source
          Placebos
          Scales
          Symptom Burden
          Severity of Illness Evaluation
          Aging
          Body Weight
          African Americans
          Sex Factors
          Psychopathology
          Patient Participation Psychosocial Factors
          Descriptive Statistics
          Data Analysis Software
          Adult: 19-44 years
          Middle Aged: 45-64 years
          Male
          Female
      ab: Background and Hypothesis This study aims to develop a placebo response and dropout rate model for acute-phase schizophrenia medication trials and assess factors affecting this response to inform future trial design. Study Design We conducted a literature update using a comprehensive meta-analysis of schizophrenia medication trials, focusing on oral placebo-controlled studies. We modeled the placebo response on the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impressions-Severity of Illness (CGI-S) scale over time and analyzed dropout rates. Influential factors were explored using covariate models and subgroup analyses. Study Results Aggregate-level data from 48 publications were analyzed. The placebo response reached a plateau at different weeks for PANSS and CGI-S scale scores. The lower the baseline of PANSS total score, older age, heavier body weight, a higher proportion of male or Black patients, smaller sample sizes, single-country trials, older studies, and the use of the Last Observation Carried Forward imputation were associated with a lower placebo response. Maximum response of PANSS Total score and gender significantly influenced dropout rates. Conclusions We present a model predicting placebo response in schizophrenia trials, offering insights into the impact of various trial characteristics, aiding in the design and interpretation of future clinical studies.
      pubtype: Academic Journal
      doctype:
        equations & formulas
        meta analysis
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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