This paper provides a new insight into an economical and effective sampling design method relying on the outcome-dependent sampling (ODS) design in large-scale cohort research. Firstly, the importance and originality of this paper is that it explores how to fit the covariate-adjusted additive Hazard model under the ODS design; secondly, this paper focused on estimating the distortion function through nonparametric regression and required observation of the covariate on the confounding factors of distortion; moreover, this paper further calibrated the contaminated covariates and proposed the estimators of the parameters by analyzing the calibrated covariates; finally, this paper established the large sample property and asymptotic normality of the proposed estimators and conducted many more simulations to evaluate the finite sample performance of the proposed method. Empirical research demonstrates that the results from both artificial and real data verified good performance and practicality of the proposed ODS method in this paper.

Phase 3 study examining adjunctive armodafinil for the treatment of a major depressive episode associated with bipolar I disorder (NCT01072929). METHODS: To assess the safety and efficacy of adjunctive armodafinil 150 mg/day in a heterogeneous sample of patients, this 8-week, double-blind, placebo-controlled, multicenter study evaluated adult patients with bipolar I disorder who were currently experiencing a major depressive episode while taking 1-2 maintenance therapies (mood stabilizers and/or second-generation antipsychotics). RESULTS:The study was conducted at 70 centers in 10 countries from January 2010 to March 2012. Of 786 patients screened, 433 were randomized. Baseline disease severity as assessed by mean (SD) IDS-C30 total scores was characteristic of moderate depression (43.6 [6.93] and 43.2 [7.76] for the placebo and 150 mg groups, respectively). The most common concomitant treatments were valproate, lithium, and lamotrigine. Patients in the placebo and armodafinil 150 mg groups experienced their first depressive episode 13.8 (SD 10.24) and 14.5 (SD 11.73) years prior to screening, respectively. The number of distinct regimens of adjunctive treatments will also be reported. CONCLUSIONS: Because the design allowed a wider range of adjunctive maintenance therapies, subjects enrolled in this study may be more representative of patients in clinical practice. The diversity of therapeutic regimens encountered in this study may improve external validity/generalizability without sacrificing assay sensitivity, although a large sample size was necessary. Further studies are needed to explore how research on bipolar depression treatments can improve external validity by employing more inclusive designs without sacrificing assay sensitivity.

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