Effects of Roluperidone (MIN-101) on two dimensions of the negative symptoms factor score: Reduced emotional experience and reduced emotional expression.
Schizophr Res
; 215: 352-356, 2020 01.
Article
em En
| MEDLINE
| ID: mdl-31488314
ABSTRACT
BACKGROUND:
Recent research has suggested that negative symptoms (NS) can be considered in terms of two different dimensions reduced expression (expressive deficit) and reduced experience (experiential deficit). Roluperidone, a compound with high affinities for 5 HT2A and sigma2 receptors, has previously shown superiority over placebo on improving NS in a prospective study in patients with schizophrenia. The objective here is to explore the effect of roluperidone compared to placebo, on the 2 domains of the Negative Symptoms.METHODS:
This was a multi-national Phase 2b trial that enrolled 244 symptomatically stable patients with schizophrenia who had baseline scores ≥20 on the NS subscale of the PANSS. Patients were randomized to daily monotherapy with roluperidone 32â¯mg, roluperidone 64â¯mg, or placebo in a 111 ratio. All enrolled patients were Caucasian, and 137 (56%) were male. The 3 treatment groups were balanced on all demographic and illness-related baseline characteristics.RESULTS:
Both doses of roluperidone were superior to placebo on both domains Reduced Experience (pâ¯≤â¯.006 for the 32â¯mg; pâ¯≤â¯.001 for the 64â¯mg) with persistent superiority from Week 2 for the 64â¯mg dose and Week 8 for the 32â¯mg dose; Reduced Expression (pâ¯≤â¯.003 for 32â¯mg; pâ¯≤â¯.001 for 64â¯mg) with similar persistence. IMPLICATIONS Both doses of roluperidone previously improved PANSS negative symptoms in general and demonstrated tolerability in stable schizophrenia patients. The post hoc analysis reported here found the drug to work on both the reduced emotional experience and reduced emotional expression sub-scales empirically derived from the PANSS.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Esquizofrenia
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Neurotransmissores
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Sintomas Afetivos
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Apatia
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Anedonia
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Indóis
Tipo de estudo:
Clinical_trials
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Diagnostic_studies
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Etiology_studies
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Observational_studies
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Risk_factors_studies
Limite:
Adolescent
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Adult
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Schizophr Res
Assunto da revista:
PSIQUIATRIA
Ano de publicação:
2020
Tipo de documento:
Article