“Big Four” News
CATIE Phase II Released
April 5, 2006
On April 1, 2006, the latest in a series of major research studies funded by the National Institute of Mental Health (NIMH) into the effectiveness of psychiatric medications was released.
Known as CATIE 2 (Clinical Antipsychotic Trials of Intervention Effectiveness), the studies are part of the “Big Four” clinical trials that include STAR*D (Sequenced Treatment Alternatives to Relieve Depression), STEP-BD (Systematic Treatment Enhancement Program) for bipolar disorder, and TADS (Treatment for Adolescent Depression Study).
CATIE, STAR*D, STEP-BD and TADS are important because unlike clinical trials conducted by private industry, their focus is longer and comparative in nature, involving “real world” conditions. They provide essential building blocks for a public research treatment "infrastructure" that can lead to newer, better medications.
Results from the second phase of STAR*D were released on March 23, 2006, the week before this latest installment in the return on public investment. Ironically, release of the studies comes at a time when President Bush has proposed cutting NIMH’s budget by $9 million. NAMI is fighting to restore the funds.
Medications Are Not Interchangeable
CATIE Phase 2 builds on an earlier study released last year, CATIE Phase I, that did not find dramatic differences in medication adherence when individuals were assigned randomly to either one old or several new antipsychotic medications.
NAMI’s analysis of CATIE I was that it raised more questions than answers. Later, NIMH also issued a clarification out of concern that state Medicaid programs might misinterpret the CATIE I results and lead them restrict formularies to cheaper, older drugs. “A one-size-fits-all policy for treating schizophrenia could be harmful, essentially turning the clock back 40 years when conventional antipsychotics were the only medications available for patients,” NIMH declared. (CATIE Phase 3 will address cost-effectiveness issues. NAMI will provide information about Phase 3 when it is released).
CATIE Phase 2 provides additional information about choices in the treatment of schizophrenia. Different individuals respond differently to different drugs. If one medication is not fully effective in treating schizophrenia, the study provides guidance to doctors about switching to or adding a second drug.
CATIE II seeks to answer a basic and common clinical question – what factors might inform decisions about further treatment when a person does not respond to an initial antipsychotic medication?
- For chronically ill individuals whose symptoms did not improve on the first medication, clozapine produced substantial reductions in symptoms and considerable improvements in medication adherence.
- For those individuals who stopped their medication in Phase I because they were experiencing psychotic symptoms, olanzapine and resperidone produced better medication adherence and better symptom reduction than ziprasidone or quetiapine.
- For people who stopped taking medication during Phase I because of side effects, no differences were noted between olanzapine, resperidone, ziprasidone or quetiapine in reducing side effects.
These results once again demonstrate that antipsychotic medications are not interchangeable. What works for one person may not work for another.
Additional background information is available online.
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