title: Limits of the applicability and generalizability of drug trials in mania.
abstract: During recent years, the majority of drug trials in mania have been conducted for the purpose of drug approval. On this background, this paper addresses to what extent these trials may actually provide the practising clinician with useful information. One major point is that selection prior to the point of randomization in RCTs in mania may limit the applicability of study results to patients seen in ordinary clinical practice. Limitations in study credibility and study design are also discussed. The need for large scale pragmatic studies using broad inclusion criteria, comparing the various treatments, alone or in combination, is emphasized.
authors.affiliation: Mood Disorders Research Unit, Aarhus University Psychiatric Hospital, Risskov, Denmark.
authors.forename: Rasmus W
authors.initials: RW
authors.lastname: Licht
mesh_terms: D018692:Antimanic Agents / Q000592:standards / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy*; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards* / Q000639:trends; D015203:Reproducibility of Results; D012107:Research Design / Q000592:standards; D018401:Sample Size
chemical_list: D018692:Antimanic Agents