LAUSR

AIMS There is growing interest in early intervention in psychotic disorders. However, gender differences in the outcomes of such treatment have not been studied in a randomized clinical trial. METHODS Patients diagnosed with schizophrenia spectrum disorders with less than 6 months antipsychotic exposure entered a cluster randomized trial of early intervention services compared to usual care in the Recovery After an Initial Schizophrenia Episode Early Treatment Program (RAISE-ETP) study. Masked evaluators assessed the Quality of Life Scale (QLS) and the Positive and Negative Syndrome Scale (PANSS) every 6 months. Our secondary analyses examined gender differences in baseline characteristics, 2-year gender outcomes, and intervention responses. RESULTS Altogether 404 individuals aged 15-40 entered the study: 111 (27.4%) women and 293 (72.5%) men. At baseline, women were significantly more likely to have been married (p = .007) and to be living independently (p = .012) than men. Women were also more likely to be diagnosed with schizoaffective disorder, bipolar type (p = .006) and scored higher on the depression subscale of the PANSS (p = .0004) but not the CDSS. Women were less likely to use or abuse cannabis (p = .0004), though no less likely to abuse alcohol. Controlling for these differences, there were no significant gender differences in the QLS or PANSS outcomes. CONCLUSION Baseline gender differences in comorbid substance use and prevalence of mood symptoms in women with first episode psychosis are consistent with previous studies. The absence of significant gender differences in outcomes with early intervention has not been previously reported in a multi-site randomized US clinical trial.