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Health-related quality of life in acute schizophrenia patients treated with RBP-7000 once monthly risperidone: An 8-week, randomized, double-blind, placebo-controlled, multicenter phase 3 study.

Abstract：

BACKGROUND:There is increased interest in the impact of new long-acting treatments on health-related quality of life (HRQoL) in patients with schizophrenia. The aim of this study was to evaluate the impact of treatment with subcutaneous injections of RBP-7000, a new sustained-release formulation of risperidone, compared with placebo on health status, subjective well-being, treatment satisfaction, and preference of medicine in subjects with acute schizophrenia. METHODS:HRQoL data were derived from an 8-week double-blind, randomized, placebo-controlled, phase 3 study that assessed efficacy, safety, and tolerability of once monthly RBP-7000 (90mg and 120mg) compared with placebo in subjects with acute schizophrenia (n=337). HRQoL was measured with the EuroQol EQ-5D-5L, well-being using the Neuroleptic Treatment-Short Version (SWN-S), satisfaction using the Medication Satisfaction Questionnaire (MSQ), and preference using the Preference of Medicine Questionnaire (POM). RESULTS:The EQ-5D-5L VAS increased significantly in the RBP-7000 120mg group compared to Placebo (p=0.0212). In RBP-7000 120mg, subjects reported significant improvements in SWN-S physical functioning (p=0.0093), social integration (p=0.0368), and total score (p=0.0395). Subjects were significantly more satisfied with RBP-7000 versus placebo (90mg p=0.0009, 120mg p=0.0006) and preferred RBP-7000 over their previous medication (90mg p<0.0001, 120mg p=0.0619). CONCLUSIONS:Significantly greater improvements in HRQoL and overall well-being were demonstrated in patients randomized to RBP-7000 compared to placebo. The effect was more pronounced in the RBP-7000 120mg group. Patient satisfaction improved significantly and patient preference for their medicine favored RBP-7000 90mg and 120mg versus Placebo.

journal_name

Schizophr Res

journal_title

Schizophrenia research

authors

Isitt JJ,Nadipelli VR,Kouassi A,Fava M,Heidbreder C

doi

10.1016/j.schres.2016.03.020

subject

Has Abstract

pub_date

2016-07-01 00:00:00

pages

126-131

issue

1-3

eissn

0920-9964

issn

1573-2509

pii

S0920-9964(16)30105-0

journal_volume

174

pub_type

杂志文章,多中心研究,随机对照试验

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Health-related quality of life in acute schizophrenia patients treated with RBP-7000 once monthly risperidone: An 8-week, randomized, double-blind, placebo-controlled, multicenter phase 3 study.