Clinically Meaningful Improvement in the treatment of Negative Symptoms of Schizophrenia: The Case of Roluperidone
Listed in
This article is not in any list yet, why not save it to one of your lists.Abstract
Background
Clinical meaningfulness in schizophrenia trials requires evidence that symptom change is recognizable in clinical practice. Established anchors include a ≥1-point improvement on the CGI-S and a ≥7-to 10-point improvement on the Personal and Social Performance scale (PSP), alongside the ≥20% improvement on the PANSS negative symptom factor score (NSFS) conventionally applied in negative-symptom trials.
Methods
These clinically meaningful anchors were applied as benchmarks to pooled 12-week completer data from two randomized, placebo-controlled trials of roluperidone in adults with schizophrenia and moderate to severe negative symptoms.
Results
Roluperidone was associated with higher responder rates than placebo on all three endpoints: ≥20% NSFS improvement (66/176 [38%] vs 39/182 [21%]; RR=1.75, 95% CI: 1.25– 2.45; p=0.0008), ≥1-point CGI-S improvement (68/167 [41%] vs 48/177 [27%]; RR=1.50, 95% CI: 1.11–2.03; p=0.0077), and ≥10-point PSP improvement (63/176 [36%] vs 44/181 [24%]; RR=1.47, 95% CI: 1.06–2.04; p=0.018). Effects were consistent across symptoms, global-severity, and functional outcomes, with no evidence of heterogeneity between studies.
Conclusions
Across all three anchor criteria, roughly 1.5 to 1.75 times as many patients treated with roluperidone as with placebo reached thresholds of improvement that clinicians and patients would recognize as clinically meaningful, supporting its relevance for persistent negative symptoms in schizophrenia.
