Introduction and Aim: Insight in schizophrenia shows critical implications for adherence. Non-adherence is particularly relevant in first-episode patients. Few studies have examined insight in early schizophrenia. The aim of this study is to examine relationship between insight, adherence and outcome in patients with early schizophrenia. Methods: Observational study in patients diagnosed for schizophrenia, schizophreniform, or schizoaffective disorder for less than 5 years. Data are collected retrospectively from first psychotic episode to study start, and prospectively (1 year). Association of demographic data, clinical measures, remission, relapses, and adherence with level of insight (Scale to Assess Unawareness of Mental Disorder and G12 item of PANSS) was evaluated. Adherence was assessed interviewing patients and family. Remission was defined according to Remission in Schizophrenia Working Group criteria. Preliminary data are shown. Results: 575 patients have been analyzed. Duration of illness was 3.9AE1.6 years. According to G12 item of PANSS, almost 50% of patients had moderate to extreme impairment in baseline insight, while this percentage was 15.8% at 12 mo. (N¼291). At baseline, 50% of patients showed good adherence to medication (>80%), and adherence rose to 78% at 12 mo. (N¼291). Remission (severity criteria) significantly increased from baseline (23.9%, N¼574) to 12 mo. (59.5%, N¼291; p<0.0001). A significant relationship between insight and remission at baseline (p<0.001) was found. Among patients who reached 12 mo. visit (N¼289), hospitalization was more frequent in those with poor baseline insight. Conclusions: Lack of insight is common in early schizophrenia and may be a relevant predictor of poor outcome.