A randomised placebo controlled trial of intensive psychosocial treatment plus or minus anti-psychotic medication for first episode psychosis with low-risk of self-harm or aggression to evaluate the impact on functioning and symptomatology. The STAGES Study: Staged Treatment and Acceptability Guidelines in Early Psychosis

This study examined whether antipsychotic medication is essential in the treatment of first episode psychosis or whether in some cases, psychological treatment can be sufficient. It was a randomised controlled non-inferiority trial that examined whether intensive psychosocial intervention for first episode psychosis in 15-25 year-olds was non-inferior to usual treatment of antipsychotic medication plus psychological treatment. This is a design that is used to assess whether a new treatment is at least as good (not inferior) as the current usual treatment. To maximise safety, participants were required to have low levels of suicidality and aggression, to have had psychosis for less than 6 months, and be living in stable accommodation with social support. The primary outcome was level of functioning at 6 months. Ninety young people were randomised by computer: 46 to placebo plus psychosocial treatment and 44 antipsychotic medication plus psychosocial treatment, and 33% of those who commenced trial medication completed the entire 6-month trial period. On the measure of functioning, both groups improved, and there were no differences between the groups on any symptoms, suggesting that medication may not be required in early treatment for all. As the study had small numbers and carefully selected participants, further studies are needed.