SA12. Baseline Demographics and Clinical Characteristics From a Prospective, Randomized, Open-Label Study of Paliperidone Palmitate Long-Acting Injection in Subjects With Recent-Onset Schizophrenia or Schizophreniform Disorder

Abstract

Abstract Background: The early, effective treatment of schizophrenia may slow disease progression and improve overall patient outcomes. The DREaM study (NCT02431702) is a doubly randomized, matched-control, open-label, flexible-dose study designed to compare the efficacy of treatment with paliperidone palmitate (PP) once monthly or once-every-3-months long-acting injection (LAI) versus treatment with oral antipsychotics in subjects with recent-onset schizophrenia or schizophreniform disorder. This abstract reports the baseline demographics and clinical characteristics of early enrollees to the study. Methods: DREaM includes 3 treatment phases. Part 1 consists of subjects who meet the inclusion/exclusion criteria and are entered into a 2-month, run-in phase to establish the tolerability of oral paliperidone prior to the next phase of study. The primary objectives of Part 2 and 3 are to examine whether PP LAI can slow disease progression and modify the course of schizophrenia when compared to oral antipsychotics. Baseline demographics and clinical characteristics have been evaluated using descriptive statistics. Results: As of September 2016, the study had enrolled 59 subjects with a mean age (± SD) of 22.5 ± 3.88 years (range, 18–35). The population is predominantly male (91.5%, 54/59); 51.7% of subjects are white and 37.9% are black. The population has a diagnosis of either schizophrenia (83.1%) or schizophreniform disorder (16.9%). Mean ± SD number of psychiatric hospitalizations within the prior 24 months is 1.2 ± 0.99, ranging from 0 to 4 hospitalizations across the population. Histories of antipsychotic exposure, categorized as 12 months of use, are 60.3%, 13.8%, and 25.9% of the population, respectively. Cumulative substance history, categorized as 0 years, ≤2 years, and >2 years, is 42.5%, 15.0%, and 42.5%, respectively. Mean ± SD MATRICS Consensus Cognitive Battery score is 27.8 ± 14.99; 40.4% of subjects had a score of <25. The screening mean ± SD Personal and Social Performance scale score is 47.7 ± 15.15 (range, 5–80); the majority of these subjects had a score of 31–70 (86.4%). Conclusion: This study population’s baseline characteristics and clinical data are representative of recently diagnosed patients with schizophrenia and will be used to match subjects in anticipation of randomization for Parts 2 and 3 of the study.