BACKGROUND: We investigated the impact of treatment with long-acting, injectable risperidone versus placebo on health-related quality of life (HRQoL) in patients with schizophrenia. Results are discussed in the context of HRQoL in the general U.S. population. METHOD:Patients with DSM-IV schizophrenia entered a randomized, double-blind, placebo-controlled trial. After screening, previous antipsychotics were discontinued, and oral risperidone was titrated up to a dose of 4 mg/day over 1 week. Patients were then randomly assigned to receive placebo [N = 92] or long-acting risperidone (25 [N = 93], 50 [N = 97], or 75 mg [N = 87] every 2 weeks) for 12 weeks. HRQoL was measured using the Medical Outcomes Study Short-Form 36-item questionnaire (SF-36). RESULTS: At week 12, patients receiving long-acting risperidone had improved significantly (p <.05) in 5 domains of the SF-36 (bodily pain, general health, social functioning, role-emotional, and mental health) compared with patients receiving placebo. The effect was greatest for the 25-mg group, with significant improvement versus placebo in 6 domains (p <.05). At baseline, all SF-36 domain scores except bodily pain were significantly lower (p <.05) than normal values in all groups. With placebo, scores in all 8 domains remained below normal values after 12 weeks, while patients receiving long-acting risperidone showed improvement in HRQoL toward normal levels, with clinically meaningful improvements in all mental-health domains. In the 25-mg group, scores in 7 domains were not statistically different from normal values after 12 weeks. CONCLUSIONS: Long-acting, injectable risperidone improved HRQoL toward normal levels. After 12 weeks, HRQoL of patients receiving 25 mg was not significantly different from normal.
RCT Entities:
BACKGROUND: We investigated the impact of treatment with long-acting, injectable risperidone versus placebo on health-related quality of life (HRQoL) in patients with schizophrenia. Results are discussed in the context of HRQoL in the general U.S. population. METHOD:Patients with DSM-IV schizophrenia entered a randomized, double-blind, placebo-controlled trial. After screening, previous antipsychotics were discontinued, and oral risperidone was titrated up to a dose of 4 mg/day over 1 week. Patients were then randomly assigned to receive placebo [N = 92] or long-acting risperidone (25 [N = 93], 50 [N = 97], or 75 mg [N = 87] every 2 weeks) for 12 weeks. HRQoL was measured using the Medical Outcomes Study Short-Form 36-item questionnaire (SF-36). RESULTS: At week 12, patients receiving long-acting risperidone had improved significantly (p <.05) in 5 domains of the SF-36 (bodily pain, general health, social functioning, role-emotional, and mental health) compared with patients receiving placebo. The effect was greatest for the 25-mg group, with significant improvement versus placebo in 6 domains (p <.05). At baseline, all SF-36 domain scores except bodily pain were significantly lower (p <.05) than normal values in all groups. With placebo, scores in all 8 domains remained below normal values after 12 weeks, while patients receiving long-acting risperidone showed improvement in HRQoL toward normal levels, with clinically meaningful improvements in all mental-health domains. In the 25-mg group, scores in 7 domains were not statistically different from normal values after 12 weeks. CONCLUSIONS: Long-acting, injectable risperidone improved HRQoL toward normal levels. After 12 weeks, HRQoL of patients receiving 25 mg was not significantly different from normal.
Authors: Ranganath D Rattehalli; Sai Zhao; Bao Guo Li; Mahesh B Jayaram; Jun Xia; Stephanie Sampson Journal: Cochrane Database Syst Rev Date: 2016-12-15