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
| Autor: | Alex Kouassi, John J. Isitt, Christian Heidbreder, Vijay R Nadipelli, Maurizio Fava |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Male endocrine system medicine.medical_specialty Phases of clinical research Placebo law.invention Young Adult 03 medical and health sciences 0302 clinical medicine Patient satisfaction Double-Blind Method Quality of life Randomized controlled trial law Humans Medicine Patient Reported Outcome Measures Biological Psychiatry Aged Psychiatric Status Rating Scales Risperidone Dose-Response Relationship Drug business.industry Middle Aged medicine.disease 030227 psychiatry Psychiatry and Mental health Treatment Outcome Tolerability Patient Satisfaction Schizophrenia Quality of Life Physical therapy Female Schizophrenic Psychology business 030217 neurology & neurosurgery Antipsychotic Agents medicine.drug |
| Zdroj: | Schizophrenia Research. 174:126-131 |
| ISSN: | 0920-9964 |
| DOI: | 10.1016/j.schres.2016.03.020 |
| Popis: | 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 (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 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. |
| Databáze: | OpenAIRE |
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