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Dr Greg Mulhauser, Managing Editor

Landmark Study Critiques Newer Antipsychotic Medications

Results of the largest and most comprehensive independent drug trial ever conducted to investigate therapies for schizophrenia suggest that five atypical antipsychotic medications are no more effective — and no safer — than an older, cheaper, drug that has largely been discontinued. The 18-month, $44 million study involved 1400 people and was funded by the US National Institute for Mental Health.

In the CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness) trial, researchers directly compared an older medication (perphenazine), available since the 1950s, to four newer medications (olanzapine, quetiapine, risperidone, and ziprasidone), introduced in the 1990s. The purpose of the study was to learn whether there are differences among the newer medications and whether the newer medications hold significant advantages over the older medications; these newer medications known as atypical antipsychotics, cost roughly 10 times as much as the older medications.

The upshot of the study is that the newest expensive antipsychotic drugs — among the most widely prescribed pills in medicine — are no more effective and no safer than the older, cheaper perphenazine. The result challenges widespread assumptions among psychiatrists about the best way to treat serious mental illness and underscores the extent to which physicians, patients and policymakers may be misled by relying on drug effectiveness research that is itself conducted by drugmakers — and all its inherent conflict of interest.

Schizophrenia, which affects 3.2 million Americans, is a chronic, recurrent mental illness, characterized by hallucinations, delusions, and disordered thinking. The medications used to treat the disorder are called antipsychotics. Previous studies have demonstrated that taking antipsychotic medication is far more effective than taking no medicine, and that taking it consistently is essential to the long-term treatment of this severe, disabling disorder. Although the medications alone are not sufficient to cure the disease, they are necessary to manage it.

A New England Journal of Medicine article is the first to report outcomes from the CATIE schizophrenia trial, and addresses many of the primary questions from the study. Future reports will address a multitude of topics (e.g., cost-effectiveness of the medications, quality of life, predictors of response) and will provide a more detailed picture of the interaction between patient characteristics, medication, and outcomes. The information from the CATIE study will inform new approaches for improving outcomes in schizophrenia.

Be sure to see the original Clinical Antipsychotic Trials of Intervention Effectiveness press release for further details.

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