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Mixed Result in Treating Schizophrenia Pre-Diagnosis
May 01, 2006
Preemptive treatment may help others ward off or even prevent psychosis, sparing them the agonizing flights of paranoia and confusion that torment the three million American who suffer schizophrenia.
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.
Click on Criteria for definitions.
Zyprexa is not FDA approved for prevention of psychosis in patients identified at high-risk. The story mentions that this was a preliminary trial and explains that the idea of identifying patients at high-risk of developing a psychotic disorder and treating them with a drug like Zyprexa is still very new, controversial and has several risks, with very limited long-term benefit.
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 adults. These drugs cost around $200/month. Add in physician visits and monitoring for onset of diabetes, weight gain, and hyperlipidemia and you can easily come up with $300/month.
The story discusses the prevalence of schizophrenia as 3 million in the U.S. According to the National Institute of Mental Health, this number is closer to 2 million. (http://www.nimh.nih.gov/publicat/schizoph.cfm)
The story mentions the trial design and that eligibility consisted of a screening instrument and evidence of early symptoms of schizophrenia. Fewer patients taking Zyprexa converted to full psychosis during the first year of treatment, but the difference between this group and the placebo group was not statistically significant. What is not mentioned is that the trial was blinded, but there was significant weight gain among the patients who took Zyprexa. As these medications are known to cause weight gain, this may have biased the clinical assessment of these patients. Additonally, 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 and experiencing early symptoms of schziphrenia, which is mentioned in the story.
Mentions primary harms of treatment as weight gain seen in this short-term trial, but there is no mention of the long term side effects or safety of Zyprexa. Diabetes and complications of the metabolic syndrome have been noted in many patients taking newer anti-psychotic medications like Zyprexa. This may be a result of the significant weight gain from the drugs. The FDA has issued an additional warning about patients developing hypoglycemia and diabetes as a result of taking Zyprexa: http://www.fda.gov/medwaTCH/SAFETY/2004/zyprexa.htm
The story mentions that this is a clinical trial. Anti-psychotic drugs are not typically used in clinical practice for the prevention or reduction in severity of psychotic episodes because of the potential for harmful side effects.
Provides some quantification of the benefit of taking Zyprexa to delay psychosis after one year of treatment, but this difference was marginally statistically significant, which is also mentioned. What the story does not report: 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 progressed despite the use of anti-psychotic medication.
No evidence this story relies on a press release. Sources other that the study authors are cited and provide some perspective on the treatment and outcome of the trial.
Mentions that Zyprexa is made by Eli Lilly and that the study was partly funded by this manufacturer (also funded by National Institute of Mental Health).
There is no mention of other treatment options for patients who show signs of psychosis or who develop schizophrenia. Psychotherapy (including cognitive behavioral therapy) in conjunction with medication has been tried with some success in other studies to help patients manage symptoms (i.e. delusions, hallucinations) and improving functioning.
Total Score: 6 of 10 Satisfactory
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