title: Adverse events during a placebo phase for inpatients with chronic schizophrenia.
abstract: BACKGROUND
  This report builds on a previous analysis examining the long-term effects of a placebo period on a group of inpatients with chronic schizophrenia. In the present analysis, outcome was evaluated through the use of the Psychiatric Adverse Events Rating Scale.
  
  
  METHODS
  This retrospective analysis examined adverse events for 55 patients with chronic schizophrenia who were placed in a double-blind placebo study on the inpatient units of the National Institute of Mental Health Neuropsychiatric Research Hospital. The number and severity of adverse events experienced by these patients during baseline, placebo, and discharge periods were analyzed.
  
  
  RESULTS
  The frequency and severity of adverse events for this group of patients were modest. Most patients did not experience a statistically significant increase in adverse events during their placebo phase; however, a subgroup of patients who were hospitalized for less than 2 months after antipsychotic medications were restored did experience a statistical elevation in adverse events, and that frequency remained statistically elevated at discharge.
  
  
  CONCLUSIONS
  The results confirm the findings from our previous analysis. Regardless of whether outcome is measured by a behavioral rating scale or by an adverse event scale, given a sufficiently lengthy recovery period, patients with chronic schizophrenia who go through a placebo phase return to baseline.
authors.affiliation: University Medical Center, Location AZU, Utrecht, Netherlands.
authors.forename: N
authors.initials: N
authors.lastname: van de Laar
authors.forename: I
authors.initials: I
authors.lastname: Henter
authors.forename: J J
authors.initials: JJ
authors.lastname: Bartko
authors.forename: R J
authors.initials: RJ
authors.lastname: Wyatt
mesh_terms: D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D004992:Ethics, Medical; D006801:Humans; D007297:Inpatients / Q000523:psychology*; D015990:Placebo Effect; D011569:Psychiatric Status Rating Scales; D012008:Recurrence; D012189:Retrospective Studies; D012559:Schizophrenia / Q000188:drug therapy* / Q000517:prevention & control; D012565:Schizophrenic Psychology
chemical_list: D014150:Antipsychotic Agents