Eight of the 14 patients completed their day 28–31 PSG, while 11 of the 14 patients completed their day 28–31 clinical assessment. Multiple check details imputation regression analysis was used to approximate missing data for PSG and clinical measures for 6 of the 14 patients who missed their day 28–31 PSG, and for three who also missed their day 28–31 clinical assessment. In

order to detect an improvement in REM sleep of approximately 45% (the published difference in REM sleep between placebo- and ziprasidone-treated healthy volunteers) [Cohrs et al. Inhibitors,research,lifescience,medical 2005], 7 patients were needed in each arm, for a total sample size of 14, based on a one-sided normal distribution paired t-test analysis with a significance of 0.05 and 80% power. A sample size of 20 patients was used to allow for patient dropout. Baseline sociodemographic and baseline PSG comparisons between groups were analyzed using two-tailed independent sample t tests. PSG recording Inhibitors,research,lifescience,medical and clinical measures (except the CGI-I) were analyzed using two-way repeated measures analysis of variance (ANOVA). The design included two treatment groups (between subjects) across three different time points

(within subjects). The linear component, change from baseline to day 28–31, was examined. The CGI-I was analyzed using a between-group t test. Inhibitors,research,lifescience,medical For all PSG and clinical measures, two-tailed distributions were used. To examine the relationship between PSG and clinical measures, first, the change from baseline to the end of the study was calculated for each measure that produced a significant time × group interaction to create standardized scores. Inhibitors,research,lifescience,medical Two-tailed Pearson correlations were then employed to examine the correlation between each set of standardized scores. All calculations were performed in IBM SPSS Statistics version 19.0. Results Polysomnographic measures The ziprasidone and placebo groups did not differ in baseline PSG Inhibitors,research,lifescience,medical measures (Table 2). A significant increase in both the latency to REM sleep and duration of SWS was observed for the ziprasidone group compared with the placebo group,

whereas duration of REM and latency to SWS were not significantly different (Table 2). Duration of stage 2 sleep also significantly improved in the ziprasidone group compared with the placebo group (Table 2). Significant improvements were observed in Nutlin-3a various sleep continuity measures, including sleep efficiency, onset to sleep latency, total sleep time, and number of awakenings (Table 2). Table 2 shows the remaining PSG measures for both the ziprasidone- and placebo-treated groups as well as p values for time × group interactions according to two-way repeated measures ANOVA. Table 2. Mean ± standard deviation of selected polysomnographic measures at baseline and at each time point during treatment with ziprasidone (N = 8) versus placebo (N = 6). Subjective sleep quality An overall significant improvement in PSQI total score was observed across time [F (1, 12) = 4.917, p = 0.047].