Personal and social adjustment effects of roluperidone in patients with schizophrenia and negative symptoms: Results from an exploratory outcome of a randomized placebo-controlled trial

Rabinowitz, Jonathan; Bădescu, Ştefan C.; Palamarchuk, Pavel; Filyk, Viktor; Voloshchuk, Anatolii; Rud, Vadym; Melnyk, Ellina; Skrypnіkov, A. M.; Davidson, Michael; Saoud, Jay; Luthringer, R.

doi:10.1016/j.schres.2019.07.029

Cited by 11 publications

(6 citation statements)

References 8 publications

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“…Unfortunately, previous attempts to target neurochemical systems that have been implicated across these conditions have generally been unsuccessful [84][85][86][87] . Since most of these drugs have primarily targeted dopaminergic mechanisms, exploration of non-dopaminergic targets may be beneficial, as there has been some recent evidence for success with drugs achieving their action via non-dopaminergic mechanisms [88][89][90] . Since such drugs have been shown to achieve their effects by impacting avolition from a network perspective, focusing on this most central component of negative symptoms may be key to observing widespread improvements in negative symptoms 37 .…”

Section: Avolition and Drug Developmentmentioning

confidence: 99%

Avolition as the core negative symptom in schizophrenia: relevance to pharmacological treatment development

2021

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Negative symptoms have long been considered a core component of schizophrenia. Modern conceptualizations of the structure of negative symptoms posit that there are at least two broad dimensions (motivation and pleasure and diminished expression) or perhaps five separable domains (avolition, anhedonia, asociality, blunted affect, alogia). The current review synthesizes a body of emerging research indicating that avolition may have a special place among these dimensions, as it is generally associated with poorer outcomes and may have distinct neurobiological mechanisms. Network analytic findings also indicate that avolition is highly central and interconnected with the other negative symptom domains in schizophrenia, and successfully remediating avolition results in global improvement in the entire constellation of negative symptoms. Avolition may therefore reflect the most critical treatment target within the negative symptom construct. Implications for targeted treatment development and clinical trial design are discussed.

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Section: Avolition and Drug Developmentmentioning

confidence: 99%

Avolition as the core negative symptom in schizophrenia: relevance to pharmacological treatment development

2021

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“… 20 Significant improvements were also found on the Personal and Social Performance (PSP) total score for the 64 mg dose ( P ≤ .003, ES = 0.59). 21 The aim of this large, multi-site trial presented here was to confirm the results of the previous trial using similar methodology. ClinicalTrials.gov Identifier: NCT03397134.…”

Section: Introductionmentioning

confidence: 57%

Efficacy and Safety of Roluperidone for the Treatment of Negative Symptoms of Schizophrenia

Davidson

Saoud

Staner³

et al. 2022

Schizophrenia Bulletin

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Background This is a placebo-controlled multi-national trial of roluperidone, a compound with antagonist properties for 5-HT2A, sigma2, and α1A-adrenergic receptors, targeting negative symptoms in patients with schizophrenia. This trial follows a previous trial that demonstrated roluperidone superiority over placebo in a similar patient population. Methods Roluperidone 32 mg/day, roluperidone 64 mg/day, or placebo was administered for 12 weeks to 513 patients with schizophrenia with moderate to severe negative symptoms. The primary endpoint was the PANSS-derived Negative Symptom Factor Score (NSFS) and the key secondary endpoint was Personal and Social Performance scale (PSP) total score. Results NSFS scores were lower (improved) for roluperidone 64 mg compared to placebo and marginally missing statistical significance for the intent-to-treat (ITT) analysis data set (P ≤ .064), but reached nominal significance (P ≤ .044) for the modified-ITT (m-ITT) data set. Changes in PSP total score were statistically significantly better on roluperidone 64 mg compared to placebo for both ITT and m-ITT (P ≤ .021 and P ≤ .017, respectively). Conclusions Results of this trial confirm the potential of roluperidone as a treatment of negative symptoms and improving everyday functioning in patients with schizophrenia. Study registration: Eudra-CT: 2017-003333-29; NCT03397134.

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“…The most frequently used measure was the PSP, which was used in a total of eleven different publications covering ten individual studies. [14][15][16][17][18][19][20]24,25,39,44 The PSP was developed from the SOFAS, which was in turn developed from the GAF. The PSP was developed by Morosini et al 48 to improve and overcome some of the limitations of the GAF and is therefore similar in structure to both the SOFAS and the GAF.…”

Section: Functional Outcome Assessment Measuresmentioning

confidence: 99%

Systematic Literature Review of Studies Reporting Measures of Functional Outcome or Quality of Life in People with Negative Symptoms of Schizophrenia

Hadzi Boskovic,

Smith-Palmer,

Pöhlmann

et al. 2024

PROM

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Personal and social adjustment effects of roluperidone in patients with schizophrenia and negative symptoms: Results from an exploratory outcome of a randomized placebo-controlled trial

Cited by 11 publications

References 8 publications

Avolition as the core negative symptom in schizophrenia: relevance to pharmacological treatment development

Avolition as the core negative symptom in schizophrenia: relevance to pharmacological treatment development

Efficacy and Safety of Roluperidone for the Treatment of Negative Symptoms of Schizophrenia

Systematic Literature Review of Studies Reporting Measures of Functional Outcome or Quality of Life in People with Negative Symptoms of Schizophrenia

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