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University Studies Show Little Progress in New Mental Health Medication

Posted on: Tuesday, 20 September 2005, 21:00 CDT

Sep. 20--DURHAM -- A sweeping pair of studies led by UNC and Duke researchers show that drug-makers have barely scratched the surface in developing useful new treatments for depression and schizophrenia in the past half-century.

The research, published by two major journals Monday, indicates that newer high-dollar brand-name drugs pushed by their makers as the best treatments for depression and schizophrenia may offer little or no real therapeutic advantage over their now-generic, and thus relatively cheap, ancestors.

One study, published in the New England Journal of Medicine, showed a schizophrenia drug used since the 1950s works about as well as the four newer ones that cost about 10 times as much. But all of them have major problems that many mental health advocates say would not be tolerated by people suffering from other kinds of chronic illnesses.

And even though olanzapine (Zyprexa), one of the newer brand-name schizophrenia drugs, may work slightly better at treating some symptoms, it also causes debilitating, potentially dangerous weight gain and cholesterol increases.

In the other study, published online Monday and to be published in the October issue of the journal Annals of Internal Medicine, UNC scientist Richard Hansen and colleagues examined the effects of 10 commonly prescribed "second-generation" antidepressant drugs such as Prozac, Zoloft, Effexor, Wellbutrin and Paxil.

Clinical depression disables more than 16 percent of adults in the United States at some time in their lives.

"Comparative evidence on these drugs suggests that there are only minimal differences in efficacy, although some of the drugs come with an increased risk of certain side effects," said Hansen, an assistant professor of pharmacy at the UNC School of Pharmacy. "Understanding the likelihood of the side effects and matching this information with patients' lifestyle and preferences for anticipated side effects may help improve drug treatment of depression."

The schizophrenia study is important because the illness affects 3.2 million Americans. It's 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 disorder.

The medications alone don't cure the disease, but they help to manage it.

UNC's Scott Stroup, associate professor in the department of psychiatry, and Joseph McEvoy, associate professor of biological psychiatry at Duke University Medical Center, were co-principal investigators in testing the schizophrenia drugs.

The $60 million, 18-month study of 1,400 patients, started in 1999, is called Clinical Antipsychotic Trials of Intervention Effectiveness, but known by the acronym CATIE. The National Institute of Mental Health, part of the National Institutes of Health, funded it, along with the Foundation of Hope of Raleigh.

In the CATIE trial, researchers compared the older drug perphenazine -- now sold only as a generic medication -- to four newer drugs: olanzapine, quetiapine (Seroquel), risperidone (Risperdal) and ziprasidone (Geodon). The study looked for differences or benefits of one drug over another.

More than 1,400 patients took part in the trial at 57 sites nationwide. CATIE sites in North Carolina included UNC, Duke University Medical Center, John Umstead Hospital in Butner, Dorothea Dix Hospital in Raleigh and the Behaviorial Health Center in Charlotte. Quintiles Transnational, of Research Triangle Park, provided logistical support.

Patients were randomly assigned to get one of the five drugs. About three-quarters of them switched from their first drug to a different drug during the study.

The researchers said they were surprised to find that movement disorders that are side effects of all the drugs -- rigidity, stiff movements and muscle restlessness -- were no worse with the older drug than with the newer ones. The older medication was tolerated as well as the newer drugs and was just as effective as three of the newer drugs.

Olanzapine was tolerated longer and reduced symptoms better, but to a modest degree, the scientists found. They said those benefits must be weighed against the drug's significant side effects. Still, the scientists said, it'll be important to do more research to explore such things as individual differences in patient response to these drugs.

Besides McEvoy, Marvin Swartz and Richard Keefe, members of the Duke psychiatry faculty, are also co-authors of the CATIE study.

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Source: The Herald-Sun

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