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

作者：Isitt John J^*; Nadipelli Vijay R; Kouassi Alex; Fava Maurizio; Heidbreder Christian

来源：Schizophrenia Research, 2016, 174(1-3): 126-131.

DOI：10.1016/j.schres.2016.03.020

• Schizophrenia
• Antipsychotic agents
• Randomized controlled trials
• Health-related quality of life

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 news ustained-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 froman 8-week double-blind, randomized, placebo-controlled, phase 3 study that assessed efficacy, safety, and tolerability of once monthly RBP-7000 (90 mg and 120 mg) 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 120 mg group compared to Placebo (p = 0.0212). In RBP-7000 120 mg, 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 (90 mg p= 0.0009, 120 mg p= 0.0006) and preferred RBP-7000 over their previous medication (90 mg p < 0.0001, 120 mg 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 120 mg group. Patient satisfaction improved significantly and patient preference for their medicine favored RBP-7000 90 mg and 120 mg versus Placebo.

• 出版日期2016-7