Adjunctive Pimavanserin in Patients with Major Depressive Disorder: Combined Results from Two Randomized, Double-Blind, Placebo-Controlled Phase 3 Studies.
Psychopharmacol Bull
; 52(4): 8-30, 2022 Oct 27.
Artigo
em Inglês
| MEDLINE | ID: covidwho-2101824
ABSTRACT
Objective:
In a phase 2 study, pimavanserin demonstrated efficacy as adjunctive treatment for major depressive disorder (MDD). Subsequently, two phase 3 studies (NCT03968159 in the US; NCT03999918 in Europe) were initiated to examine the efficacy and safety of adjunctive pimavanserin in subjects with MDD and inadequate response to antidepressant treatment. Studies were combined with a prespecified statistical analysis plan owing to recruitment challenges related to the COVID-19 pandemic. Experimentaldesign:
The randomized, double-blind studies enrolled 298 patients with MDD and inadequate response to current antidepressants. Patients were randomly assigned 11 to pimavanserin or placebo added to current antidepressant for 6 weeks. Primary endpoint was change from baseline to week 5 in the Hamilton Rating Scale for Depression, 17-item version (HAM-D-17). Principal observations There was no effect of pimavanserin in change from baseline to week 5 in the HAM-D-17 (pimavanserin [n = 138] least-squares mean [LSM] [standard error {SE}], -9.0 [0.58]; placebo [n = 135] -8.1 [0.58]; mixed-effects model for repeated measures LSM [SE] difference, -0.9 [0.82], P = 0.2956). Nominal improvement with pimavanserin was observed on 2 secondary endpoints Clinical Global Impressions-Severity scale, Karolinska Sleepiness Scale. Treatment-emergent adverse events occurred in 58.1% of pimavanserin-treated and 54.7% of placebo-treated patients.Conclusions:
Adjunctive pimavanserin did not significantly improve depressive symptoms, although pimavanserin was well tolerated.Palavras-chave
Texto completo:
Disponível
Coleções:
Bases de dados internacionais
Base de dados:
MEDLINE
Assunto principal:
Transtorno Depressivo Maior
/
COVID-19
Tipo de estudo:
Estudo experimental
/
Estudo observacional
/
Estudo prognóstico
/
Ensaios controlados aleatorizados
Limite:
Humanos
Idioma:
Inglês
Revista:
Psychopharmacol Bull
Ano de publicação:
2022
Tipo de documento:
Artigo
País de afiliação:
Estados Unidos
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