Schizophrenia Daily News Blog

New Study on Schizophrena Relapse Prevention -

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," said 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 said.

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," said 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% of U.S. patients use them, compared to 30 to 40% 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 said.

"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," said 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 said. 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," said 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," said 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."

Treatment will be administered by research staff, so that scientists can closely track adherence and assess whether injections result in better outcomes than do daily pills. The success of the injectable versus the oral medications will be measured by comparing how long patients go without relapsing into psychosis, using criteria such as frequency of psychiatric hospitalizations or visits to the emergency room, suicide attempts, and acting-out episodes.

Recruitment for the trial recently began at seven study sites and is expected to continue for at least two years. The trial includes patients 18 to 65 years old who are living in the community as outpatients — a reflection of real-world schizophrenia care today — and whose symptoms are moderate, but have worsened in the last year.

Patients with schizoaffective disorder (schizophrenia combined with a mood disorder, such as depression or bipolar disorder) also are eligible to participate. Patients living in long-term care hospitals and those having their first episode of schizophrenia will not be included in the trial.

Of the 304 patients to be included, half will be randomly assigned to take the injectable form of the medication risperidone. The remaining patients will take an oral medication chosen from among the five available in the trial: the oral form of risperidone, olanzapine, quetiapine, ziprasidone, or aripiprazole. Other new oral medications that enter the market while the study is underway may be added to the choices.

For Details on How to Participate in this Research Study - Please click on the following link: Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy (PROACTIVE)