Mixed Result in Treating Schizophrenia Pre-Diagnosis

Our Review Summary

This story discusses a randomized, double-blind trial of Zyprexa for the prevention or delay of schizophrenia in high-risk young adults experiencing early symptoms of psychosis (schizophrenia is a more severe, chronic psychotic disorder). Due to potentially serious side effects, Zyprexa and similar anti-psychotic drugs are not currently FDA approved for prevention of schizophrenia in patients identified at high-risk of developing this psychotic disorder.

The story mentions that this was a small clinical trial and the idea of identifying patients at high-risk of developing a psychotic disorder and treating them with a drug like Zyprexa is still new and has several risks, with very limited long-term benefit. There is no mention of other treatment options for patients who show signs of psychosis or who go on to develop schizophrenia. The story mentions some of the harms of treatment with Zyprexa seen in this short-term trial, but there is no mention of the long-term side effects or safety of taking this medication. Diabetes and complications of the metabolic syndrome have been noted in many patients taking newer anti-psychotic medications, including Zyprexa. This may be a result of the significant weight gain from the drugs. The FDA has issued an additional warning hypoglycemia and diabetes as a result of taking Zyprexa: http://www.fda.gov/medwaTCH/SAFETY/2004/zyprexa.htm

The story lists the limited benefit of taking Zyprexa to delay psychosis after one year of treatment, but this difference was only marginally statistically significant. The story does not mention that after the medication was stopped, these patients showed more severe psychotic symptoms than when they were first recruited for the study, suggesting that while symptoms were blunted, the disorder had progressed despite anti-psychotic medication. Additionally, many of the patients did not complete the study, so from the 60 initially recruited, only 12 completed the full 2-year trial. Results from such a small number of patients would not be generalizable to a larger population of patients at high risk of developing a psychotic disorder.

There is no mention of the cost of Zyprexa and no mention of how long this medication would need to be taken to prevent a severe psychotic break in susceptible young adults. There is appropriate discussion that Zyprexa is made by Eli Lilly and that the study was partly funded by this manufacturer and the National Institute of Mental Health. Sources other than the study authors are cited and provide some perspective on the treatment and outcome of the trial.