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3 May 2006

For young people with the early signs of schizophrenia, treatment with the antipsychotic olanzapine could lower or delay the rate of conversion to full-blown psychosis, researchers report.

They estimate that between four and five people meeting the criteria for prodromal symptoms would need to be treated in order to prevent one conversion to psychosis over a 1-year period.

Thomas McGlashan, from Yale University School of Medicine in New Haven, Connecticut, USA, and colleagues randomly assigned 60 patients showing prodromal signs of psychosis to receive either 5–15 mg/day of olanzapine or placebo for 1 year. The patients were participating in the Prevention Through Risk Identification, Management, and Education project.

During the year of treatment, 37.9% of patients taking placebo experienced a conversion to psychosis, compared with just 16.1% of those treated with olanzapine, reflecting a difference that was close to significance.

The hazard of conversion among placebo-treated patients was about 2.5 times that for patients given olanzapine.

In the follow-up year, after treatment was discontinued, only 17 patients remained in the trial. Among these, five patients converted to psychosis in the second year: three formerly treated with olanzapine and two treated with placebo.

If olanazapine truly prevents the transition to psychosis rather than just delaying it, the researchers would have expected there to be few, if any, conversions in the second year. However, due to the small number of patients, the study was underpowered to establish this.

While the overall difference in conversion to psychosis between the two groups did not reach statistical significance, McGlashan and team report in the American Journal of Psychiatry that the average score for prodromal positive symptoms improved more in the olanzapine-treated group.

However, the olanzapine-treated patients gained more weight than those taking placebo, at an average of 8.79 kg versus 0.30 kg. But there were no blood laboratory values suggestive of diabetes or cardiovascular disease.

The investigators conclude: "The nearly significant difference between treatment groups in the conversion rate points to the possibility that olanzapine might reduce the rate of conversion to psychosis and delay the onset of psychosis."

They add: "We feel that this clinical trial demonstrates that the benefits of pre-onset identification and treatment outweigh the risks to a degree sufficient to endorse future clinical trials… so that definitive recommendations on use of antipsychotics to treat the prodromal phase of schizophrenia can be made."



Source: Am J Psychiatry 2006; 163: 790–799
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