Informed consent in medication-free schizophrenia research

Am J Psychiatry. 2005 Jun;162(6):1209-11. doi: 10.1176/appi.ajp.162.6.1209.


Objective: The authors' goal was to determine whether people with schizophrenia experience changes in decisional capacity when their antipsychotic regimens are discontinued for research purposes.

Method: Capacity for informed consent for research, neuropsychological performance, and psychiatric symptoms were assessed before and after discontinuation of antipsychotic medication in 10 individuals with schizophrenia.

Results: Overall, participants showed minimal change on most measures during the medication-free interval, although their reasoning ability declined significantly. All participants who demonstrated adequate understanding of study procedures at enrollment retained this capacity throughout the study.

Conclusions: Participants in medication-free schizophrenia research do not show a major decline in decisional capacity. However, the apparent decline in reasoning ability found in this study is of concern and underscores the need for both additional research on this topic and the development of remediational interventions aimed at enhancing this aspect of decisional capacity.

Publication types

  • Comparative Study
  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Antipsychotic Agents / therapeutic use
  • Cognition Disorders / diagnosis
  • Cognition Disorders / psychology
  • Decision Making
  • Female
  • Humans
  • Informed Consent / standards*
  • Male
  • Mental Competency / standards*
  • Neuropsychological Tests / standards
  • Patient Selection
  • Psychiatric Status Rating Scales
  • Research Subjects / psychology*
  • Schizophrenia* / diagnosis
  • Schizophrenia* / drug therapy
  • Schizophrenic Psychology


  • Antipsychotic Agents