Original Research December 15, 2013

Prospective Trial of Customized Adherence Enhancement Plus Long-Acting Injectable Antipsychotic Medication in Homeless or Recently Homeless Individuals With Schizophrenia or Schizoaffective Disorder

Martha Sajatovic, MD; Jennifer Levin, PhD; Luis F. Ramirez, MD; David Y. Hahn, MD; Curtis Tatsuoka, PhD; Christopher S. Bialko, MA; Kristin A. Cassidy, MA; Edna Fuentes-Casiano, MSSA; Tiffany D. Williams, BS

J Clin Psychiatry 2013;74(12):1249-1255

Article Abstract

Background: Treatment nonadherence in people with schizophrenia is associated with relapse and homelessness. Building on the usefulness of long-acting medication and our work in psychosocial interventions to enhance adherence, we conducted a prospective uncontrolled trial of customized adherence enhancement (CAE) plus long-acting injectable antipsychotic (LAI) using haloperidol decanoate in 30 homeless or recently homeless individuals with DSM-IV-defined schizophrenia or schizoaffective disorder.

Method: Participants received monthly CAE and LAI (CAE-L) for 6 months. Primary outcomes were adherence, as measured by the Tablets Routine Questionnaire, and housing status. Secondary outcomes included psychiatric symptoms, functioning, side effects, and hospitalizations. The study was conducted from July 2010 to December 2012.

Results: The mean age of participants was 41.8 years (SD = 8.6); they were mainly minorities (90%, n = 27 African-American) and mainly single/never married (70%, n = 21). Most (97%, n = 29) had past or current substance abuse and had been incarcerated (97%, n = 29). Ten individuals (33%) terminated the study prematurely. CAE-L was associated with good adherence to LAI (at 6 months, 76%) and dramatic improvement in oral medication adherence, which changed from missing 46% of medication at study enrollment to missing only 10% at study end (P = .03). There were significant improvements in psychiatric symptoms (P < .001) and functioning (P < .001). Akathisia was a major side effect with LAI.

Conclusions: While interpretation of findings must be tempered by the methodological limitations, CAE-L appears to be associated with improved adherence, symptoms, and functioning in homeless or recently homeless individuals with schizophrenia or schizoaffective disorder. Additional research is needed on effective and practical approaches to improving health outcomes for homeless people with serious mental illness.

Trial Registration: ClinicalTrials.gov identifier: NCT01152697

J Clin Psychiatry 2013;74(12):1249-1255

Submitted: December 13, 2012; accepted March 14, 2013 (doi:10.4088/JCP.12m08331).

Corresponding author: Martha Sajatovic, MD, Departments of Psychiatry and Neurology, University Hospitals of Cleveland, 11100 Euclid Ave, Cleveland, OH ([email protected]).

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