Medication-Free Research in Early Episode Schizophrenia: Evidence of Long-Term Harm?

This study investigates the question of whether short periods of medication-free research in early episode schizophrenia result in demonstrable long-term harm to human subjects. A meta-analysis of published quasi-experimental and random assignment studies that had a majority of first- or second-episode schizophrenia spectrum subjects, at least 1 initially unmedicated group, and a minimum of 1-year results was conducted. Only 6 studies, with 623 subjects, met inclusion criteria. The initially unmedicated groups showed a small, statistically nonsignificant long-term advantage (r = -0.09). Incorporating only random assignment studies into a composite effect size produced a similar near-zero result (r = 0.01). Good-quality evidence is inadequate to support a conclusion of long-term harm resulting from short-term postponement of medication in early episode schizophrenia research. A categorical prohibition against such research should be reconsidered.