New data from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE), sponsored by the National Institute of Mental Health (NIMH), show that while antipsychotic medications may be effective in significantly improving symptoms in patients with schizophrenia, those symptomatic improvements do not appear to translate into significant improvements in overall quality of life.
CATIE was an 18-month, $42.6 million, multisite, “real world” clinical trial that compared the effectiveness of second-generation antipsychotic medications (SGAs) with a representative first-generation antipsychotic (FGA) in nearly 1,500 patients with chronic schizophrenia.
Marvin Swartz, M.D., a professor of psychiatry at Duke University and a CATIE clinical investigator, along with other study co-investigators, reported in the March American Journal of Psychiatry the quality-of-life outcomes from phase 1 of the complex three-phase CATIE protocol. The report is the fifth in a series detailing the many outcome measures studied in phases 1 and 2 of the trial. Outcomes from phase 3 have not yet been published.
“CATIE continues to fine-tune our understanding of how our arsenal of antipsychotic medications work in real-world settings, but it also is revealing to us what questions we still must address,” said NIMH Director Thomas Insel, M.D., in a prepared statement.
“Helping patients with schizophrenia to restore their psychosocial functioning remains a challenge,” Insel said. “These CATIE results reinforce the growing understanding that we must do a better job of helping patients get their life skills back on track.”
Swartz and his colleagues evaluated the social and vocational functioning, interpersonal relationships, and psychological well-being of the 30 percent of CATIE participants (455 out of the 1,493 who started the study) who stayed on their initially assigned medication for at least 12 months in phase 1 of the protocol. During phase 1, patients were randomly assigned to receive either the FGA perphenazine or one of several SGAs—olanzapine (Zy prexa), quetiapine (Seroquel), risperidone (Risperdal), or ziprasidone (Geodon).
The researchers found that patients who stuck with their initial treatment showed some improvement in their psychosocial functioning, but there were no differences among the medications in achieving these gains. The results are consistent with those previously reported from CATIE, in which few significant differences were seen between perphenazine and the newer SGAs in reducing symptoms or time to discontinuation.
The patients who made the greatest gains were those with the poorest community-living skills at the beginning of the study, but they were also more likely to discontinue treatment early in the process.
“Over the long run patients are more likely to function better in the community if they are able to stay on their initial treatment, especially those who are the most impaired,” Swartz said during a telebriefing for the media. “More intensive rehabilitative interventions and outreach may help patients stick with their treatment and make greater gains.”
Patients who made few gains in community-living skills were those with higher-level psychosocial skills at the beginning of the study. Swartz and his colleagues hypothesized that patients encountered a “ceiling effect” at which point additional psychosocial skill improvement was unlikely without additional rehabilitative treatment.
“Overall, the findings reiterate the widely held belief that antipsychotic medications alone are not sufficient in helping patients make meaningful gains in real-world functioning,” said Swartz.“ Dedicated rehabilitative services that help patients learn to function at work and in social settings are sorely needed.”