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."
"Effects of Antipsychotic Medications on Psychosocial
Functioning in Patients With Chronic Schizophrenia: Findings From the NIMH
CATIE Study" is posted at<http://ajp.psychiatryonline.org/cgi/content/abstract/164/3/428>.▪