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Báo cáo y học: "Onset of efficacy with acute long-acting injectable paliperidone palmitate treatment in markedly to severely ill patients with schizophrenia: post hoc analysis of a randomized, double-blind clinical trial"

Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học General Psychiatry cung cấp cho các bạn kiến thức về ngành y đề tài: Onset of efficacy with acute long-acting injectable paliperidone palmitate treatment in markedly to severely ill patients with schizophrenia: post hoc analysis of a randomized, double-blind clinical trial. | Alphs et al. Annals of General Psychiatry 2011 10 12 http www.annals-general-psychiatry.eom content 10 1 12 ANNALS OF GENERAL PSYCHIATRY PRIMARY RESEARCH Open Access Onset of efficacy with acute long-acting injectable paliperidone palmitate treatment in markedly to severely ill patients with schizophrenia post hoc analysis of a randomized double-blind clinical trial 1 1 12 1 Larry Alphs Cynthia A Bossie Jennifer K Sliwa Yi-Wen Ma and Norris Turner Abstract Background This post hoc analysis trial registration ClinicalTrials.gov NCT00590577 assessed onset of efficacy and tolerability of acute treatment with once-monthly paliperidone palmitate PP a long-acting atypical antipsychotic initiated by day 1 and day 8 injections in a markedly to severely ill schizophrenia population. Methods Subjects entering the 13-week double-blind trial were randomized to PP 39 156 or 234 mg 25 100 and 150 mg eq of paliperidone respectively or placebo. This subgroup analysis included those with a baseline Clinical Global Impressions-Severity CGI-S score indicating marked to severe illness. PP subjects received a 234-mg day 1 injection deltoid followed by their assigned dose on day 8 and monthly thereafter deltoid or gluteal . Thus data for PP groups were pooled for days 4 and 8. Measures included Positive and Negative Syndrome Scale PANSS CGI-S Personal and Social Performance PSP and adverse events AEs . Analysis of covariance ANCOVA and last-observation-carried-forward LOCF methodologies without multiplicity adjustments were used to assess changes in continuous measures. Onset of efficacy was defined as the first time point a treatment group showed significant PANSS improvement assessed days 4 8 22 36 64 and 92 versus placebo which was maintained through end point. Results A total of 312 subjects met inclusion criterion for this subgroup analysis. After the day 1 injection mean PANSS total scores improved significantly with PP all received 234 mg versus placebo at day 4 P 0.012 and day 8