Ten Questions on CATIE

1. What is CATIE

CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness) is the first large scale attempt to compare five different medications used to treat people living with schizophrenia. The study included both newer (atypical) and one older anti-psychotics. The study was funded by the National Institute of Mental Health (NIMH) and included 1400 subjects. The duration of the study was 18 months.

2. What medications were studied?

New medications in the study included olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal), and ziprasidone (Geodon). Perphenazine (Trilafon) was included as a representative of the older generation of anti-psychotics.

3. What are the key findings from the report?

In general terms, the study found that there was relatively little difference in the effectiveness of any of the medications. Without regard to which medication was assigned, patients discontinued the use of medications at similar rates due to intolerable side effects or failure to adequately control symptoms. One of the newer medications, olanzapine, did fare slightly better in terms of symptom reduction, duration of treatment, and lower rate of hospitalizations. However, the investigators concluded that the (moderate) benefits of olanzapine should be weighed carefully against the risks associated with weight-gain and metabolic side effects for that compound.

4. Is CATIE the final word on this subject?

The principal investigator in CATIE, Jeffrey Liebermann, M.D., emphasizes that the way individuals respond to specific medications are still not adequately understood. In short, anti-psychotic medications are not interchangeable. A variety of factors, including past treatment history and other medications being taken must be considered in clinical decisions about the most appropriate medication to prescribe. NAMI advocates can use this report in making the argument that clinical judgment, not economics should guide decisions about which medications to prescribe to specific individuals. And, they can use this study to make the point that prescribers need reasonable access to all medications so that prescriptions can be issued with as few obstacles as possible.

5. Are the findings of the report reliable?

NAMI believes that this report represents a reasonable first effort to scientifically approach a very complicated set of issues. However, this report, which addresses only Phase I of the CATIE study, does not provide definitive answers to the complex questions surrounding which medications work best for various individuals with schizophrenia. In fact, as is the case with much research, the report raises more questions than provides answers. For example, the researchers only studied one of the older medications, Perphenazine, and did not include some of the more commonly prescribed older medications such as Haldol, which frequently have serious neurological side effects known as extrapyramidal symptoms (EPS) and movement disorders such as Tardive Dyskinesia. And, Phase I of the study did not include clozapine(Clozaril) which, of all the so-called newer atypical medications, has had a dramatically positive impact on the lives of many people with previously intractable (untreatable) schizophrenia for many people since its approval by the FDA in 1990.

Additionally, the protocols for the study required that patients be “randomized” to one of the five drugs. This randomization does not reflect best clinical practice which calls for a dialogue between a medical professional and consumer that helps determine a best-choice medication based upon treatment goals and risk of side-effects.

Other shortcomings of the report include the studies duration and disqualifying criteria. At only 18 months in length, the study did not allow adequate time for the irreversible symptoms of (TD) to present. Also, people with TD were disqualified from using Perphenazine but people at risk of diabetes were not excluded from using the four atypical agents.

6. Does this mean that I/my family member should contemplate a medication change?

All treatment decisions are individual and unique. There is no “one size fits all” in any aspect of treatment. If you think your treatment is working, then stay with it.

At the systems level, patients and their support system should be skeptical of any attempt to change medications if treatment is demonstrating progress. NAMI believes the state can never be in the practice of medicine. The report demonstrates that adherence is a key challenge in the treatment of schizophrenia. NAMI advocates should challenge any efforts to alter treatment strategies that are currently productive. And, advocates should resist any efforts by private insurance companies or public payors (e.g. Medicaid) to limit access to medications, particularly for individuals who are doing well on specific medications. Physicians are best prepared to give advice on this topic; not policy makers or administrative personnel.

7. What changes will this report prompt in formulary policies?

It is likely that policy makers will use this report as an excuse to tighten formularies and introduce additional restrictive policies. In public programs, reports like this one provide policy makers cover to introduce strategies that cut costs. Within weeks, NAMI will be providing advocates tools that will be useful in medication access discussions.

8. How will this alter NAMI’s public policy on access to medications?

NAMI’s policy on access to medications continues to stress that prescribing decisions are best left in the hands of physicians and other prescribers, with the input and involvement of consumers. CATIE has not changed this as the report demonstrates that different people tolerate medications differently and different side effects require customization of treatment.

NAMI will continue to advocate for access to a range of medication options and adequate patient protections to assure that consumers have access to those medications that his/her doctor believes are most appropriate.

9. CATIE looked at schizophrenia. How about other mental illnesses?

NIMH has funded a series of similar studies looking at other serious mental illnesses. STAR-D (depression), STEP-BD (bipolar disorder) and last year’s release of TADS (Treatment for Adolescents with Depression Study). CATIE also has an arm looking at Alzheimer’s.

10. Where can I learn more about the report?

A full copy of the report is available at the following web address:

http://content.nejm.org/cgi/content/abstract/NEJMoa051688

Over the next several weeks, NAMI will be providing grassroots leaders additional resources on the CATIE study and advocacy tools that can be used as background information for the public debate on this topic that is likely to surface in state capitols across the country.

Ten Questions on CATIE

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