May 11, 2007

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)


This kind of study has already been done in Europe and the results were that injectibles improved outcomes. It would have been nice if this study had also included some of the older antipsychotics. It is interesting to note that every antipsychotic being used in this study is an atypical and that all of them are available only as brand name antipsychotics.

Posted by: cannonier at May 11, 2007 06:07 PM

I thought much the same. It was interesting that the only injectable used in this study is risperdine consta (a very costly and expensive medication). I would be nice to see the use of the typical injectables such as haldol or prolixin as well.
from an anticdotal standpoint, I have seen the negative symptoms in schizophrenia decreased with risperidone consta but felt that the positive symptoms were decreased with either.

Posted by: bob at May 13, 2007 07:09 AM

I note that I was on fluanxol injectable until side effects had my doctor switching to risperadol pills. I was much improved with fluanxol. It is not so much the discipline of taking pills as though it were a battle but instead I had to want to get better. You can't force medications they must be taken willingly. The fluanxol helped me by simplifying the regime. As did the risperadol which was simple "take two pills at night". Keep it simple. Want to get better. Don't force treatment on adults. I was also more recently in a double blind study into injectable risperadol.

Posted by: Peter T at May 15, 2007 01:58 AM

I agree very much with Peter T comment about not forcing patients to use medication. Notwistanding researches say that the new antypsychotic have less side effects, and help people with schizophrenia reducing positive symptoms, I think that in adult patients decision about if taking or not medication must be left to the patient, provided wide information. Here in Europe (particularly in Italy, where human rights in health system are not so considered) I suppose it's not unusual that relatives give medication to the schizophrenic patients secretly. Why don't fund a research about it?

Posted by: Pietro Barbetta at June 15, 2007 02:26 PM

Maybe fewer schizophrenics would relapse if we could get back to basics in caring for them after an acute psychotic good food, good sleep habits and decreasing stress. I have some ideas here about sleep in particular...

Posted by: Petr at August 19, 2007 02:27 AM

My mother has schizophrenia and we have struggled with her taking her meds for years (38 years). She had 8 good years (thanks to Seroquel), but in the last 18 months she decided to no longer take her meds and has been in and out of hospitals and finally in a nursing home. She is now at her home (for 2 months) and we are already having problems with her taking her meds. She says that "someone that knows more than her doctor" told her she's taking too many meds and she does not need to take some of them. Of course, she is VERY delusional (she thinks my dad is alive and is coming to get her and he died 7 years ago), so the "voices" are telling her this. How do we deal with this? She lives alone and none of her children live close (and her living with them is not an option). She does take a risperdel injection every two weeks along with Seroquel & Depacote (orally), but her voices are getting worse (Seroguel no longer works like it did). Is an assisted living facility our only option? She's only 69 years old and will probably live another 15 years and when she's taking her meds, she's not 100%, but maybe 80% and can function on her own (cooking, bathing,laundry, cleaning, shopping, social activity, etc.), so the nursing home seems restrictive. Is home health an option? Have you found this is helpful with patients not taking their meds? She is VERY smart and can hide things very well and they would have to come three times a day. Any advice or experiences would be VERY HELPFUL!

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