July 27, 2005

CATIE Study - New Schizophrenia Treatment Standards Coming

In the coming months the results of a recently-completed study funded by the National Institutes of Mental Health (NIMH) will be published.

The study is called CATIE, "The Clinical Antipsychotic Trials of Intervention Effectiveness project" and is comprised of four trials that look at 1)serious depression 2)bipolar disorder 3)schizophrenia 4)adolescent depression.

In the schizophrenia-focused CATIE study, the research compared eight antipsychotic drugs against each other to determine their comparative effectiveness and safety. Approximately 1,600 patients were enrolled in the study, and the participant's reactions to the drugs were tracked for an 18 month period.

In the first stage of the schizophrenia study, patients are given either perphenazine (an older, generic antipsychotic medication) or one of four newer drugs: Eli Lilly & Co.'s Zyprexa, Johnson & Johnson's Risperdal, AstraZeneca PLC's Seroquel or Pfizer's Geodon. If they don't get better or encounter side effects, they are switched to other antipsychotics, including the newest, Abilify from Bristol-Myers Squibb Co.

The study's main goal is to give unbiased results that will consider how effective the different (older and newer) antipsychotics truly are when compared simultaneously and over a long term trial. Many trials done by drug companies are short and do not take into account the long-term affects of their drugs. As Abboud states in The Wall Street Journal, many drug companies have trials that run for only about 8 to 12 weeks, "And, in order to stay focused on a drug's efficacy on one illness, they exclude the sickest patients and people with co-existing disorders."

The results from this trial will likely have a huge impact in how people with schizophrenia are treated in the USA (and around the world) potentially transforming the way patients are treated and, the Wall Street Journal has suggested, "shaking up some of the drug industry's most lucrative markets".

The problems that the CATIE trials are designed to address is, in part, that the FDA's clinical trials don't answer some of the key questions that doctors say that they really need. The FDA clinical trials only tell if a new drug is "safe", and if it at least meets some minimum level of effectiveness. What the trials don't do is compare one drug with another. The problem, therefore, is that psychiatrists don't have any indepth studies to help guide them on whether one drug works better than another, or has fewer side effects than another. These are the types of questions that the CATIE study is designed to help answer.

While the study results have not yet been released - one early and interesting piece of information is that in the trial approximately 70% of the patients didn't do well on their first drug, and had to be switched to a new one. While the issue of switching medications has been a common issue in the schizophrenia.com discussion boards, I don't think anyone knew it was such a high percent of people.

The CATIE study marks a true milestone in the treatment of people with schizophrenia. As Price (2004) states, "According to the project's website, industry-sponsored research--which has recently dominated clinical psychopharmacology research--is critical to new product development. However, its emphasis is on meeting regulatory and marketing requirements and on obtaining expanded marketing claims for the drug, not on evaluating the effectiveness of the product at the general population level. As a result, industry-sponsored research does not address broad public health needs or the needs of individual practitioners seeking to make good clinical decisions for individual patients."

This study will help to learn whether newer drugs are more effective than older drugs. Atypical antipsychotics have received a lot of positive press in comparison to the older typical antipsychotics, but whether one is more effective than the other is arguable. Many studies use data from previous studies on typical antipsychotics and compare it to data that is done (in the present) by them on atypical antipsychotics. This is known as using "a last observation carried forward approach" (Price, 2004). Which gives an extreme bias towards atypical antipsychotic medication. Also, most studies do not compare one drug to another, rather they are done simply to see whether that particular antipsychotic can quell symptoms in patients. This does not give clinicians the insight needed to determine which antipsychotics are most effective or which give fewer side effects.

Data for the study was collected at 57 sites around the country. Patients were brought into the study in 2001 and the study was completed in 2004. The results are now being analyzed before results are published. As Moyer (2005) stated, "The goal of the study is to determine effectiveness of the drugs in typical treatment circumstances, so that patients included those who were substance abusers and those with comorbid medical conditions, as long as those conditions were stable, unlike clinical trials that typically exclude such patients." This gives even more credibility to the accuracy of the results that are published.

The CATIE study website can be found at: http://www.catie.unc.edu/schizophrenia/

The sources of this article were:
Abboud, L. (2005, July 27). The next phase in psychiatry: Largest ever studies on drugs for depression, schizophrenia could transform treatment. [Electronic Version]. The Wall Street Journal, Page D1.

Moyer, P. (2005, May 27). Metabolic syndrome seen in schizophrenia patients. (A study done/funded by a pharma company Retrieved July 27, 2005. See also:http://tinyurl.com/7jr94

Price, L. H. (2004, February 1). Schizophrenia treatment: should conventional antipsychotics be shelved in favor of newer agents?Olanzapine vs. Haloperidol Study. Psychopharmacology Update.


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