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National Institutes of Health

Science Update
September 5, 2006

New Schizophrenia Trial: Does Method of Administering Medication Make a Difference?

A new clinical trial is testing whether an injection of a long-lasting antipsychotic medication every two weeks results in better adherence to treatment and better outcomes among people with schizophrenia than do oral medications taken daily. The $10 million trial is being funded by the National Institutes of Health's National Institute of Mental Health (NIMH) and is called Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared to Injectables –– Evaluating Efficacy (PROACTIVE). Patients can participate for any 2.5-year period during the 5 years that the study will be offered. The study will be conducted at seven sites across the country and will include only newer, second-generation antipsychotic medications.

About 1 percent of U.S. adults, or 2.4 million, have schizophrenia, which is among the most serious of mental illnesses. Its symptoms, such as loss of contact with reality (for example, hearing voices and having false beliefs and hallucinations), disordered thinking, flat emotions, and social withdrawal, can lead to long-term disability.

The study is addressing a major challenge in the treatment of schizophrenia: how best to encourage long-term treatment and medication adherence. Research has shown that people with schizophrenia who consistently take antipsychotic medications fare better than those who do not. These medications help prevent symptoms and relapse and reduce hospitalizations. However, many patients stop taking medications or take them sporadically.

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.

Trial sites and contact information:

To find out about how to participate in the PROACTIVE study, click on this internet link for detailed contact information:

Please use the following identifier when contacting study sites: identifier NCT00330863.

Study sites are listed below:

Medical College of Georgia, Department of Psychiatry, Augusta, Georgia
Principal Investigator: Peter F. Buckley, M.D.

University of Iowa College of Medicine, Psychiatry Research, Iowa City
Principal Investigator: Del D. Miller, PharmD, M.D.

Harvard Medical School - Massachusetts General Hospital, Boston, Massachusetts
Principal Investigator: Donald Goff, M.D.

Harvard Medical School - Dr. John C. Corrigan Community Mental Health Center, Fall River, Massachusetts
Principal Investigator: Theo Manschreck, M.D.

Creighton University, Omaha, Nebraska
Principal Investigator: Daniel R. Wilson, M.D., Ph.D.

New Mexico
University of New Mexico, Albuquerque, New Mexico
Principal Investigator: John Lauriello, M.D.

New York
The Zucker Hillside Hospital, Glen Oaks, New York
Principal Investigator: Alan Mendelowitz, M.D.

Study chairs or principal investigators:

John M. Kane, M.D., Principal Investigator, Steering and Implementation Center
Nina R. Schooler, Ph.D., Study Director, Steering and Implementation Center
Stephen R. Marder, M.D., Study Director, Steering and Implementation Center

To learn more about schizophrenia and about other schizophrenia studies funded by the National Institute of Mental health, please visit the following internet site: