Assessment of effectiveness measures in patients with schizophrenia initiated on risperidone long-acting therapy: the SOURCE study results

Wayne Macfadden, Cherilyn DeSouza, Concetta Crivera, Chris M Kozma, Riad D Dirani, Lian Mao, Stephen C Rodriguez, Wayne Macfadden, Cherilyn DeSouza, Concetta Crivera, Chris M Kozma, Riad D Dirani, Lian Mao, Stephen C Rodriguez

Abstract

Background: To evaluate effectiveness outcomes in a real-world setting in patients with schizophrenia initiating risperidone long-acting therapy (RLAT).

Methods: This was a 24-month, multicenter, prospective, longitudinal, observational study in patients with schizophrenia who were initiated on RLAT. Physicians could change treatment during the study as clinically warranted. Data were collected at baseline and subsequently every 3 months up to 24 months. Effectiveness outcomes included changes in illness severity as measured by Clinical Global Impression-Severity (CGI-S) scale; functional scores as measured by Personal and Social Performance (PSP) scale, Global Assessment of Functioning (GAF), and Strauss-Carpenter Levels of Functioning (LOF); and health status (Medical Outcomes Survey Short Form-36 [SF-36]). Life-table methodology was used to estimate the cumulative probability of relapse over time. Adverse events were evaluated for safety.

Results: 532 patients were enrolled in the study; 209 (39.3%) completed the 24-month study and 305 (57.3%) had at least 12 months of follow-up data. The mean (SD) age of patients was 42.3 (12.8) years. Most patients were male (66.4%) and either Caucasian (60.3%) or African American (23.7%). All changes in CGI-S from baseline at each subsequent 3-month follow-up visit were statistically significant (p < .0001), indicating improvement in disease severity. Improvements were also noted for the PSP, GAF, and total LOF, indicating improvement in daily functioning and health outcome.

Conclusions: Patients with schizophrenia who were initiated on RLAT demonstrated improvements in measures of effectiveness within 3 months, which persisted over 24 months.

Trial registration: ClinicalTrials.gov: NCT00246194.

Figures

Figure 1
Figure 1
Improvement from baseline in Clinical Global Impression-Severity (CGI-S) score. Scores are presented as least-squares (LS) means except for the baseline value, which is unadjusted. Patients included in this analysis were those who had a baseline and at least one follow-up assessment of their CGI-S score. *Changes from each visit compared with baseline (visit 1) were significant at p < .0001.
Figure 2
Figure 2
Improvement from baseline in Personal and Social Performance (PSP) score. Scores are presented as least-squares (LS) means except for the baseline value, which is unadjusted. Patients included in this analysis were those who had a baseline and at least one follow-up assessment of their PSP score. *Changes from each visit compared with baseline (visit 1) were significant at p < .0001.
Figure 3
Figure 3
Improvement from baseline in Global Assessment of Functioning (GAF) score. Scores are presented as least-squares (LS) means except for the baseline value, which is unadjusted. Patients included in this analysis were those who had a baseline and at least one follow-up assessment of their GAF score. *Changes from each visit compared with baseline (visit 1) were significant at p < .0001.
Figure 4
Figure 4
Improvement from baseline in Strauss-Carpenter Levels of Functioning (LOF) total score. Scores are presented as least-squares (LS) means except for the baseline value, which is unadjusted. Patients included in this analysis were those who had a baseline and at least one follow-up assessment of their LOF score. *Changes from each visit compared with baseline (visit 1) are significant at p < .0001.
Figure 5
Figure 5
Conditional probability of relapse by visit. P, probability.
Figure 6
Figure 6
Least-squares (LS) mean Clinical Global Impression-Severity (CGI-S) change from baseline by visit and discontinuation status. Patients included in this analysis were those who had 24 months of data and had all nine visits and at least one RLAT injection record in the injection log. Model: CGI-S Change From Baseline = Baseline CGI-S Value + Visit + Stayed On/Dropped Off Maker + Visit*Drop Off Interaction Term. p-values were generated from a model using ranks of CGI-S change from baseline as the dependent variable. *All values except visit 7 were significant at p < .05; for visit 7, p = .2081.
Figure 7
Figure 7
Least-squares (LS) mean Personal and Social Performance (PSP) change from baseline by visit and discontinuation status. Patients included in this analysis were those who had 24 months of data and had all nine visits and at least one RLAT injection record in the injection log. Model: PSP Change From Baseline = Baseline PSP Value + Visit + Stayed On/Dropped Off Maker + Visit*Drop Off Interaction Term. p-values were generated from a model using ranks of PSP change from baseline as the dependent variable. *All values except visit 3 were significant at p < .05; for visit 3, p = .1309.
Figure 8
Figure 8
Least-squares (LS) mean Global Assessment of Functioning (GAF) change from baseline by visit and discontinuation status. Patients included in this analysis were those who had 24 months of data and had all nine visits and at least one RLAT injection record in the injection log. Model: GAF Change From Baseline = Baseline GAF Value + Visit + Stayed On/Dropped Off Maker + Visit*Drop Off Interaction Term. p-values were generated from a model using ranks of GAF change from baseline as the dependent variable. *All values were significantly different at p < .05.

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