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Questions and Answers About the NIMH Clinical Antipsychotic Trials of Intervention Effectiveness Study (CATIE)

1. What is the CATIE study?

A: The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Study, funded by the NIH's National Institute of Mental Health, is a nationwide public health focused clinical trial comparing the effectiveness of older (first available in the 1950s) and newer (available since the 1990s) antipsychotic medications used to treat schizophrenia. These newer medications, known as atypical antipsychotics, cost roughly 10 times as much as the older medications. CATIE is the largest, longest, and most comprehensive independent trial ever done to examine existing therapies for this disease. Schizophrenia is a brain disorder characterized by hallucinations, delusions, and disordered thinking. The course of schizophrenia is variable, but usually is recurrent and chronic, often causing severe disability. Previous studies have shown that taking antipsychotic medications consistently is far more effective than taking no medicine and that the drugs are necessary to manage the disease. The aim of the CATIE study was to determine which medications provide the best treatment for schizophrenia.

2. Why is CATIE important?

A: Many studies have tested new antipsychotic medications in schizophrenia. Most of these were conducted by pharmaceutical companies, to obtain Food and Drug Administration (FDA) approval to market a new drug. These studies were usually short-term (4 to 8 weeks), focused on limited outcomes, enrolled a narrow range of patients, and studied only one or two medications at a time. By contrast, CATIE compared four of the newer medications to one another, and to an older medication. Participants in CATIE were followed for 18 months so that investigators could evaluate longer-term patient outcomes. The more than 1400 participants in the study included those with physical or other mental health problems in addition to schizophrenia. CATIE was conducted at many different treatment sites, broadly representative of the real life settings where patients receive their care. The results from CATIE will be applicable to the wide range of people with schizophrenia in the United States.

3. How will the results of CATIE affect the care doctors provide patients?

A: For the first time, doctors and people with schizophrenia will have extensive information on antipsychotic medications from a single, large, long-term study directly comparing the drugs to each other. CATIE greatly enhances the knowledge available to guide treatment choices for people with schizophrenia. CATIE provides new information on the efficacy and side effects of antipsychotic drugs, compared head to head, helping doctors determine the appropriateness of specific medications in individual patients. The combination of maximizing the benefits while minimizing the side effects increases the likelihood that a person with schizophrenia will stay on their antipsychotic medication, a necessary ingredient for managing symptoms and reducing the risk of relapse.

4. Which medications were studied in CATIE and how was medication chosen for each patient?

A: All medications included in the study were FDA-approved antipsychotic medications used in the treatment of schizophrenia. No placebo treatments were used. Patients were randomly assigned to a medication; study participants and their doctors could not choose which medication to take, and neither the investigators nor the patients knew which antipsychotic a patient was on. This type of study, a "double-blind randomized clinical trial," produces objective results, since researchers' and participants' will have no expectations about how well a medication might work to influence the outcome. In the first phase of CATIE, patients were randomly assigned to one of four newer, "atypical" antipsychotics: olanzapine (Zyprexa^®), quetiapine (Seroquel^®), risperidone (Risperdal^®), and ziprasidone (Geodon^®); or to the older, "typical" medication, perphenazine (Trilafon^®). Dose range for each medication was chosen based on advice from experienced clinicians, clinical practice patterns from national pharmacy databases, and discussions with the drug manufacturers. Patients continued to take this medication for the next 18 months, or until the medication could not control their symptoms adequately, or they developed an intolerable side effect, or they decided to stop the medication, or withdraw from the study for some other reason.

continue: CATIE Study Medications

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Written: 9/2005. Reviewed: 03/2006