Do we need oxytocin to treat schizophrenia? A randomized clinical trial.

Background: Schizophrenia is a disabling complex mental disorder and despite all available treatment, many patients unfortunately remain partial- or non-responders. A large body of research has shown that oxytocin is an important prosocial peptide and there is initial evidence that the central oxytocin system is altered in several mental disorders. The aim of this study was to test the efficacy of oxytocin, as augmentation therapy, in a sample of patients with schizophrenia.

A multi-element psychosocial intervention for early psychosis (GET UP PIANO TRIAL) conducted in a catchment area of 10 million inhabitants: study protocol for a pragmatic cluster randomized controlled trial.

Background: Multi-element interventions for first-episode psychosis (FEP) are promising, but have mostly been conducted in non-epidemiologically representative samples, thereby raising the risk of underestimating the complexities involved in treating FEP in 'real-world' services.

Methods/design: The Psychosis early Intervention and Assessment of Needs and Outcome (PIANO) trial is part of a larger research program (Genetics, Endophenotypes and Treatment: Understanding early Psychosis - GET UP) which aims to compare, at 9 months, the effectiveness of a multi-component psychosocial intervention versus treatment as usual (TAU) in a large epidemiologically based cohort of patients with FEP and their family members recruited from all public community mental health centers (CMHCs) located in two entire regions of Italy (Veneto and Emilia Romagna), and in the cities of Florence, Milan and Bolzano. The GET UP PIANO trial has a pragmatic cluster randomized controlled design.