Psychosocial Intervention with or without Antipsychotic Medication for First Episode Psychosis: A Randomized Noninferiority Clinical Trial

Abstract

This triple-blind (participants, clinicians and researchers) randomised controlled non-inferiority trial examined whether intensive psychosocial intervention (Cognitive-behavioural Case Management, CBCM) for first episode psychosis in 15-25 year-olds managed in a specialised early intervention for psychosis service was non-inferior to usual treatment of antipsychotic medication plus CBCM delivered during the first six months of treatment.To maximise safety, participants were required to have low levels of suicidality and aggression, a duration of untreated psychosis of less than 6 months, and be living in stable accommodation with social support. The primary outcome was level of functioning as assessed by the SOFAS at 6 months.

Ninety young people were randomised by computer, 46 to placebo and 44 antipsychotic medication and 33% of those who commenced trial medication completed the entire 6 month trial period. On the SOFAS, both groups improved, and group differences were small and clinically trivial, indicating that treatment with placebo medication was no less effective than conventional antipsychotic treatment (Mean Difference=-0.2, 2-sided 95% confidence interval -7.5 to 7.0, t=0.060, p=0.95).

Within the context of a specialised early intervention service, and with a short duration of untreated psychosis, the immediate introduction of antipsychotic medication may not be required for all cases of first episode psychosis in order to see functional improvement. However, this finding can only be generalised to a very small proportion of FEP cases at this stage, and a larger trial is required to clarify whether antipsychotic-free treatment can be recommended for specific subgroups of those with FEP.

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