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. 2017 Aug 1;47(3):8–16.

Baseline Demographics and Characteristics From a Paliperidone Palmitate Study in Subjects with Recent-Onset Schizophrenia or Schizophreniform Disorder

Brianne Brown 1, Larry Alphs 1, Ibrahim Turkoz 1, Yong Yue 1
PMCID: PMC5546555  PMID: 28839335

Introduction

  • Early and effective treatment of schizophrenia may slow disease progression and improve overall patient outcomes.1 In addition, interventions specifically targeting cognitive deficits may prevent chronic disability2

  • In individuals with first-episode schizophrenia, greater improvements have been reported with long-acting injections vs oral antipsychotics (APs)3,4

  • The Disease Recovery Evaluation and Modification (DREaM) study is examining whether paliperidone palmitate once-monthly (PP1M) followed by paliperidone palmitate once-every-3-months (PP3M) injections can slow disease progression and possibly modify the course of schizophrenia compared with oral APs in subjects with recent-onset psychosis (schizophrenia or schizophreniform disorder) by tracking changes in cognition, functioning, and intracortical myelin volume and by tracking treatment failures

  • Key innovations of the DREaM study include double randomization of matched-control subjects in a delayed-start design. This study design is used to distinguish between a treatment’s effect on symptom improvement and potential disease modification5

  • We describe the baseline demographics and clinical characteristics of early enrollees to the DREaM study

  • These characteristics are compared to those of subjects enrolled in a trial evaluating a similar population: the Recovery After an Initial Schizophrenia Episode (RAISE) study, a multisite, randomized controlled trial in subjects with first-episode psychosis6

Methods

Study Designs

DREaM (NCT02431702)

  • DREaM is a prospective, matched-control, double-randomized, open-label, flexible-dose study in subjects with recent-onset schizophrenia or schizophreniform disorder that compares disease progression and disease interception following treatment with PP1M/PP3M or oral APs

  • Subjects aged 18 to 35 years with a DSM-5 diagnosis of schizophrenia or schizophreniform disorder and first psychotic episode within 2 years of enrollment are eligible

  • Participating sites include academic- and community-based clinics both with and without established clinics that specialize in first-episode psychosis

  • DREaM includes three treatment phases (Figure 1)

Figure 1.

Figure 1

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DREaM Study Design

RAISE

  • Subjects were aged 15 to 40 years with a DSM-IV diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder not otherwise specified

  • All participants had experienced only one episode of psychosis and had received ≤6 months of AP medications in their lifetime

  • Participating sites included 34 community mental health centers in the United States

  • Academic centers or sites with existing first-episode psychosis programs were excluded from participation6

DREaM Screening/Baseline Efficacy Assessments

  • The following assessments were performed at either screening (visit 1) or baseline (Part 1: visit 2, day 1):
    • ○ Baseline demographics and clinical characteristics
    • ○ MATRICS Consensus Cognitive Battery (MCCB)7: Measured key cognitive domains relevant to schizophrenia and related disorders
    • ○ Personal and Social Performance (PSP) scale8: Assessed personal and social functioning within the past month
    • ○ Clinical Global Impression of Severity (CGI-S) scale9: Rated the severity of the subject’s overall clinical condition on a 7-point scale (1 = not ill, 7 = extremely ill)
    • ○ Medication Satisfaction Questionnaire (MSQ)10,11: Rated self-reported satisfaction with current AP treatment on a 7-point Likert scale (1 = extremely dissatisfied, 7 = extremely satisfied)
    • ○ Clinician-Rated Dimensions of Psychosis Symptom Severity (CRDPSS)12: An 8-item measure that assesses the severity of mental health symptoms that are important across psychotic disorders, such as delusions, hallucinations, disorganized speech, abnormal psychomotor behavior, negative symptoms, impaired cognition, depression, and mania, on a 5-point scale (0 = none, 4 = present and severe)

Statistical Analyses

  • Baseline demographics and clinical characteristics were generated for the DREaM study using descriptive statistics. In some cases where data were available, demographics and clinical characteristics were compared between the DREaM and RAISE studies

  • Study comparisons for available data points were carried out using either the chi-squared test for categorical data or the t-test for continuous data points

Results

DREaM vs RAISE Study

  • The DREaM study had enrolled 96 subjects as of April 4, 2017

  • Baseline demographics in the DREaM and RAISE studies were similar, except for a predominance of males and differences in living status and patient/maternal education in the DREaM study as compared to the RAISE study (Table 1). Some of these differences may be driven by site differences

  • The psychiatric history of subjects enrolled in the DREaM and RAISE studies are compared in Table 2. Most characteristics were similar except for the CGI-S rating, suggesting slightly higher disease severity in the DREaM sample at the time of study entry

  • The median duration of time since the first episode of psychosis (regardless of treatment status) at screening was 11.1 months. In RAISE the median duration of untreated psychosis was approximately 17 months, suggesting that these subjects took longer to begin treatment6

  • The history of AP exposure and current AP treatment at screening for subjects enrolled in DREaM is shown in Table 3

  • In comparison, all subjects in RAISE were required to have <6 months of exposure, and 83% were prescribed one or more APs at baseline6

Table 1. Baseline Demographics in the DREaM and RAISE Studies.

BASELINE CHARACTERISTIC DREaM: ENROLLED SUBJECTS N = 96 RAISE: FINAL POPULATION6 N = 404 P VALUE
Age, y, mean (SD) 22.8 (4.0) 23.1 (5.1) 0.512
Sex, male, n (%) 83 (86) 293 (73) <0.001
Race, n (%) 0.094
 White 47 (49) 218 (54) –
 Black 33 (34) 152 (38) –
 Other 15 (16) 34 (8) –
 Missing data 1 (1) – –
Ethnicity, n (%) 0.043
 Hispanic or Latino 27 (28) 73 (18) –
Living status, n (%) <0.001
 Independent living 1 (1) 72 (18) –
 Supported or structured 2 (2) 14 (3) –
 With family/friends 86 (90) 287 (71) –
 Homeless/other 7 (7) 31 (8)
Patient education, n (%) <0.001
 Some college or higher 29 (30) 125 (31) –
 Completed high school 56 (58) 133 (33) –
 Some high or grade school 11 (11) 125 (31) –
 No school or unknown 0 21 (5) –
Maternal education, n (%) 0.014
 Some college or higher 49 (51) 167 (41) –
 Completed high school 30 (31) 111 (27) –
 Some high or grade school 13 (14) 59 (15) –
 No school or unknown 4 (4) 67 (17) –
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Abbreviation: SD, standard deviation.

Table 2. Psychiatric History of Subjects Enrolled in DREaM vs RAISE.

DREaM: ENROLLED SUBJECTS N = 96 RAISE: FINAL POPULATION6 N = 404 P VALUE
Current diagnosis 0.414
 Schizophrenia, n (%) 77 (80) 214 (53) –
 Schizophreniform disorder, n (%) 19 (20) 67 (17) –
 Other, n (%) 0 123a –
Months since first psychotic episode
 Mean (SD) 12.2 (7.1) – NA
 Median (range) 11.1 (2–25) – –
CGI-S 0.002
 Mean (SD) 4.4 (1.0) 4.1 (0.8) –
 Range 2–7 – –
Total number of prior hospitalizations NA
 Mean (SD) 1.2 (1.2) – –
 Range 0–6 – –
Number of prior hospitalizations, n (%) 0.145
 0 28 (29) 88 (22) –
 1 33 (34) 181 (45) –
 2 21 (22) 69 (17) –
 ≥3 12 (13) 64 (16) –
 Missing data 2 (2) 2 (0.5) –
Cumulative substance history, n (%) NA
 <6 months 2 (2) – –
 6–12 months 1 (1) – –
 >12 months 59 (61) – –
 Missing data, n (%) 34 (35) – –
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Notes: aA total of 123 subjects in the RAISE study had psychotic diagnoses other than schizophrenia or schizophreniform disorder.

Abbreviations: NA, not applicable.

Table 3. AP Treatment at Screening for DREaM Subjects.

DREaM SUBJECTS N = 96
Duration of prior AP exposure, n (%)
 <6 months 48 (50)
 6–12 months 16 (17)
 >12 months 23 (24)
 Missing data, n (%) 9 (9)
Current AP treatment at screening,a n (%)
 Risperidone 25 (26)
 Paliperidone 18 (19)
 Olanzapine 12 (13)
 Haloperidol 8 (8)
 Quetiapine 8 (8)
 Aripiprazole 6 (6)
 Lurasidone hydrochloride 3 (3)
 Other 3 (3)
 Loxapine 1 (1)
 Ziprasidone hydrochloride 1 (1)
 Not assignedb 22 (23)
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Notes: aDrugs selected if they are used on the reference start date or 2 weeks before it.

bSubjects who were not assigned to any medications.

Additional Clinical Characteristics of DREaM

  • Most subjects enrolled in DREaM (80%) had a CGI-S score of ≥4, which is indicative of a population that is moderately to extremely ill (Figure 2)

  • At baseline, there was a wide range of satisfaction with current AP medication, with the most common response being “somewhat satisfied” (27%; Figure 3)

  • The mean ± SD MCCB score is 28.2 ± 13.9; 42% of subjects had a score of ≤25 (Figure 4)

  • The screening mean ± SD PSP scale score is 49.5 ± 14.6 (range, 5–80). Most subjects had a score of 31 to 70 (86%), indicating a moderate degree of social dysfunction at baseline (Figure 5)

  • The most severe CRDPSS ratings were observed in delusions, negative symptoms, and impaired cognition (Figure 6)

Figure 2.

Figure 2

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Baseline CGI-S Scale

Figure 3.

Figure 3

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Medical Satisfaction as Assessed Using the MSQ at Screening (N = 96)

Figure 4.

Figure 4

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Cognition as Assessed Using the MCCB at Screening (N = 93)

Figure 5.

Figure 5

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Baseline PSP Scale Total Scores (A) and Domain Scores (B)

Figure 6.

Figure 6

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Frequency of CRDPSS Item Ratings at Screening

Limitations

  • Between the two studies, there were differences in both inclusion criteria and research site types

  • The DREaM study sample presented here represents only one-third of the planned enrollment. Thus, it may not reflect the full population to be studied

Discussion

  • Most subjects with recent-onset psychosis enrolled in the DREaM study had at least one prior hospitalization, a history of substance use, a CGI-S score of ≥4, and a moderate degree of social dysfunction

  • With a few exceptions, the baseline demographics and characteristics of subjects in the DREaM study appear similar to those reported in the RAISE study in subjects with first-episode psychosis receiving treatment at US community mental health centers

  • The DREaM study population’s baseline characteristics and clinical data represent those of a population recently diagnosed with schizophrenia and will be used to match subjects in anticipation of randomization for Parts 2 and 3 of the study

Acknowledgments

The authors thank Matthew Grzywacz, PhD, and Lynn Brown, PhD, of ApotheCom (Yardley, PA) for their writing and editorial assistance.

Footnotes

Presented at the American Psychiatric Association Annual Meeting, May 20–24, 2017, San Diego, CA.

Disclosures

B. Brown, L. Alphs, and Y. Yue are employees of Janssen Scientific Affairs, LLC, and are Johnson & Johnson stockholders. I. Turkoz is an employee of Janssen Research and Development, LLC, and is a Johnson & Johnson stockholder.

References

Articles from Psychopharmacology Bulletin are provided here courtesy of MedWorks Media Inc.

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