Monthly intramuscular injections of paliperidone were significantly more effective than oral antipsychotics in maintaining patients with schizophrenia who were recently released from jail, according to a paper presented May 3 at the annual meeting of the American Psychiatric Association.
The PRIDE (Paliperidone Palmitate Research in Demonstrating Effectiveness) study "is the first prospective, randomized clinical trial to study schizophrenia treatments within the context of many ‘real world’ issues faced by patients in their daily lives, including some of the most challenging circumstances – recent incarceration or substance use," Dr. Mark Lerman, a PRIDE principal investigator, said in an interview. "Until now, no studies have been conducted comparing the effectiveness of psychopharmacologic treatments in individuals with schizophrenia following release from jail."
Dr. Mark Lerman
The PRIDE trial looked at time to treatment failure in 444 schizophrenia patients over 15 months – 226 were treated with IM paliperidone (Invega Sustenna) and 218 were treated with one of seven oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, or risperidone). Time to treatment failure was defined as arrest/incarceration; psychiatric hospitalization; suicide; treatment discontinuation or supplementation due to inadequate efficacy, safety, or tolerability; or increased psychiatric services to prevent hospitalization.
All participants were adults diagnosed with schizophrenia who had been taken into custody by the criminal justice system at least twice in the previous 2 years, with at least one custody resulting in incarceration, said Dr. Lerman, medical director at the Center for Psychiatric Research at Alexian Brothers Behavioral Health Hospital in Hoffman Estates, Ill. All participants were released from their most recent custody within 90 days of screening for the trial.
IM paliperidone was associated with a significantly longer time to treatment failure than oral antipsychotics, with a median time of 416 days vs. 226 days (P = .011).
The most common treatment-emergent adverse events were injection-site pain (18.6% in patients on IM paliperidone vs. 0% on oral antipsychotics), insomnia (16.8% vs. 11.5%), weight gain (11.9% vs. 6.0%), akathisia (11.1% vs 6.9%), and anxiety (10.6% vs 7.3%).
Dr. Lerman stressed the importance of including "real world" adverse consequences in the study of schizophrenia, since mental illness patients represent a substantial proportion of the incarcerated population.
"When severely mentally ill individuals, including those with schizophrenia, are released from correctional facilities, many of them return to environments with limited support and without consistent medication or follow-up services," Dr. Lerman said. "This lack of continuous care when reentering the community can result in a ‘revolving door’ of relapse, rearrest, incarceration, and hospitalization.
"Lack of access to consistent community care may lead some individuals to cycle through jails dozens or even hundreds of times," Dr. Lerman said. "In addition to the impact on patients, these factors have created an increasingly large and costly problem for the U.S. health care system."
Dr. Lerman’s institution received funding from Janssen Pharmaceuticals. The study was sponsored by Janssen, which manufactures paliperidone.
mrajaraman@frontlinemedcom.com
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