Ethics in placebo-controlled, acute treatment trials in schizophrenia: Two rival ethical frameworks.

Placebo-controlled, acute treatment trials in schizophrenia enroll acutely symptomatic persons, randomize them to receive placebo or antipsychotic medication for several weeks, and evaluate whether symptoms improve. These trials can have scientific benefits, especially when they test drugs with novel mechanisms of action. However, the use of placebo is ethically problematic inasmuch as standard treatment is withheld and participants are subjected to prolonged psychotic symptoms and associated risks. We propose that both deontological (duty-based) and utilitarian analyses are relevant, that it may be impossible to satisfy the ideals of both frameworks, and that researchers who conduct these trials will unavoidably encounter ethical tension and criticism even when they give careful attention to ethical aspects of study design.