This observational study tracked the clinical outcome of 110 severely agitated patients who received Geodon IM (intramuscular formulation). Initial agitation levels were high, ranging from 6.5 to 6.9 on a scale that ranges from a high of 7.0 to a low of zero. Within 30 minutes, whether the patients were psychotic, or had abused alcohol or drugs, their agitation scores dropped to a normal range. In addition to quickly relieving agitation, the results of the new study showed a reduction in physical restraints. The time period severely agitated patients treated with Geodon IM were held in restraints dropped by 40 percent compared to the period prior to this study when similar agitated patients received conventional antipsychotics--primarily haloperidol, known by the brand name Haldol. For more than 50 years, Haldol IM has been considered the gold standard of injectable antipsychotics, but its side effect profile offers disadvantages for patients. Approved in 2002, Geodon IM is the first second generation antipsychotic approved for the rapid control of acute agitation in patients.
"Being held in physical restraint is not only unpleasant, it also can be unsafe," said Andrew Francis, M.D., Ph.D., study investigator and director of inpatient psychiatry at Stony Brook University Hospital. "Using it is a last resort. We want to minimize the exposure to it as much as possible," he said, adding that reducing the time in restraints, and the time patients are agitated, might also reduce time spent in the emergency room and thus reduce costs." Dr. Francis added that the results showed a "trend toward shorter overall stays in the Emergency Department."
Horacio Preval, M.D., lead author of the study and director of psychiatric emergency services at Stony Brook University Hospital, said that having patients in restraints for a shorter period of time offers substantial benefits. "Reducing the time in restraints lowers the chance for complications. This new medication really does represent a significant new option in emergency treatment of severely agitated patients, particularly because it's effective in treating agitation, whatever the apparent cause," he said.
Doctors recommend that patients treated with an intramuscular injection be transitioned to the same medication in an oral formulation. The study followed the outcome of 110 patients who were brought to the hospital's Psychiatric Emergency Service suffering from acute agitation who were given Geodon. Of these, 72 were suffering only from psychiatric conditions, 10 had abused alcohol, and 28 had abused various forms of drugs.
The study's authors cautioned that this observational study was not a blinded, controlled design, because it is difficult to obtain consent from severely agitated patients, and called the work a "naturalistic" study, which reflects actual clinical practices.
Stony Brook University Hospital is celebrating its 25th anniversary in 2005. With its 504 beds and 4,000 employees, Stony Brook is the largest hospital in Suffolk County and is Long Island's only academic medical center. The new Heart Center and the Long Island Cancer Center attract patients throughout the region for their cutting edge diagnostic and treatment facilities and advanced care. Stony Brook has Long Island's only kidney transplantation center and the nation's only Pediatric Multiple Sclerosis Center. The hospital is also the regional referral center for trauma, perinatal and neonatal intensive care, burns, bone marrow and stem cell transplantation, cystic fibrosis, pediatric/adult AIDS, and is home to the Cody Center for Autism and Developmental Disabilities.