Subscribe X
Back to Top


March 27, 2020 by Shona M Francey, PhD et al | Schizophrenia Bulletin

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


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.

Full manuscript PDF

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Related Blogs

  • Dr. David Healy

    Dr. David Healy

    Dr. Healy is a professor of psychiatry at Cardiff University in Wales and an author on the history of pharmaceuticals and government regulation.
  • Mad In America: Robert Whitaker

    Mad In America: Robert Whitaker

    Journalist and author Bob Whitaker distills the latest in pharmaceutical and mental health research.
  • Selling Sickness

    Selling Sickness

    Creating a new partnership movement to challenge the selling of sickness.
  • Kathy Brous

    Kathy Brous

    A serial of Kathy's recovery journey as an adult with attachment disorder.
  • Nev Jones

    Nev Jones

    Exploring the intersections of psychiatry, philosophy, neuroscience, cultural theory, critical community psychology and the mad/user/survivor movement.
  • 1boringoldman


    Retired psychiatrist and raconteur offers insightful analysis of the day's events from the woods of Georgia.