Study compares delivery methods of schizophrenia medicines

More than half of schizophrenia patients don't take their medication as directed and a new study will determine whether biweekly physician visits and injectable drugs can change that.

"The basic thing we are comparing is whether people who get the injectable medicine will do better either in their symptoms or their functioning and have less relapses over 30 months of treatment," says Dr. Peter Buckley, chair of the Medical College of Georgia Department of Psychiatry and Health Behavior.

"Compliance with oral medication is such a problem, particularly in people with schizophrenia, that we think the injectable form of this new medicine will outperform other medicines because people will simply take it more," he says.

Dr. Buckley is a principal investigator on the five-year, $10 million study, Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared to Injectables - Evaluating Efficacy, funded by the National Institute of Mental Health.

Other study sites include University of Iowa College of Medicine, Massachusetts General Hospital and Dr. John C. Corrigan Community Mental Health Center at Harvard Medical School, Creighton University in Omaha, the University of New Mexico, Albuquerque and The Zucker Hillside Hospital in Glen Oaks, N.Y.

The PROACTVE study will follow 304 outpatients age 18 to 65 at seven centers whose disease relapsed within the last six months because they did not take their medicines properly or became resistant to them. These patients tend to be "the sickest of the sick," says Dr. Buckley, often requiring hospitalization.

MCG will enroll 38 patients, including those at two public mental health centers, Ogeechee Behavioral Health Services and Serenity Behavioral Health Systems.

Participants will take a commonly prescribed antipsychotic pill - the usual treatment in this country - or injections of risperidone microspheres, an injectable version of a relatively new antipsychotic. With risperidone microspheres, the medicine is placed in the same material used for biodegradable sutures so it can work its way into the body over about two weeks.

Injectable antipsychotics have been around since the 1970s, but only about 5 percent of U.S. patients use them, compared to 30 to 40 percent of European patients. "It's not because the drugs are any better or worse in two different continents. They're the same drugs. It's got to do with how we make treatment decisions," Dr. Buckley says.

"Some doctors in the U.S. believe injections are a violation of patient autonomy. With a pill, you can always stop it the next day; here you have something that is going to stay in the system," says Dr. Buckley, who chairs the National Institutes of Health's Interventions Committee for Schizophrenia Spectrum Disorders, Personality Disorders and Disorders of Late Life.

Older oral medications and their injectable counterparts have numerous side effects including drowsiness, constipation, weight gain and Parkinson-like movements. Newer drugs, including oral and injectable forms of risperidone, share many of these but there is some evidence side effects are less frequent, Dr. Buckley says. Older injectables also are delivered in oil, a downside for some patients who find the injection painful.

Researchers hope this new study, which mimics usual treatment choices, will provide a realistic comparison of the new injectable and standard oral medicines. To help ensure impartial findings, participants also will be evaluated every few months via telemedicine by health professionals not regularly involved in their care.

"This study gives us the opportunity to really test over a good long period of time an important development in our field and to test it in broad settings to see whether it will make a difference for these patients," says Dr. Buckley.

"Maybe just the contact every two weeks will help people do better. But if this package of regular visits and injectable medicine reduces relapse rates, it will provide a tremendous quality of life benefit for patients and be economically advantageous as well."

"Relapse is the nature of the disease," says Dr. Philip Horton, medical director at Serenity Behavioral Health System. About half the center's 6,000 patients, residents of Richmond, Columbia, McDuffie, Wilkes, Warren and Taliaferro counties, have schizophrenia. "The same people come back over and over again; they stop their medications and relapse. Participating in this study will be good for us and our patients."

At Ogeechee Behavioral Health Services, which serves Burke, Emanuel, Glascock, Jefferson, Jenkins and Screven counties, about 60 percent of patients have schizophrenia or schizophrenia-like disease, says Dr. Mona Hanna, assistant medical director.

Drs. Hanna and Horton already use injectable medicines for some patients and welcome the head-to-head comparison. "We have our own opinions based on our clinical experiences," says Dr. Hanna. "But to actually know would be very intriguing and in the best interest of our patients."

"Conducting this study at public mental health facilities like Serenity and Ogeechee Behavioral Health Services is a great boost to this research, since it is in centers like these that the study's results are likely to have the greatest impact," says Dr Thomas Bornemann, executive director of the Mental Health Program at the Carter Center in Atlanta.

"This study provides an excellent opportunity for assisting in the transformation of the mental health system here in Georgia."

"It is an honor to have such a prominent study based in Augusta and in our state," says Carole Ferrang, president of the Augusta Chapter of the National Alliance for the Mentally Ill, the main support organization for patients and their families.

Schizophrenia affects about 1 percent of the population or some 2.4 million American adults. Hallucinations are a disease hallmark: patients hear voices and can even see, touch and taste things that are not real. They can become aggressive, reclusive and suicidal and have an increased risk of cardiovascular and other health conditions. The average life expectancy of schizophrenics is 15 years less than that of the general population.

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