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Intra-Cellular Therapies Reports Positive Final Results of a Phase II Clinical Trial with ITI-007 in Patients with Sleep Maintenance Insomnia
Date:3/10/2009

al sleep time (p<0.001), decreased total time awake (p<0.001) and improved sleep efficiency (calculated by the proportion of the time spent sleeping while in bed, p<0.001).

Intra-Cellular Therapies believes that ITI-007 promotes natural, restorative sleep. In particular, ITI-007 did not cause rebound insomnia during early morning hours and did not suppress rapid eye movement (REM) sleep as some hypnotic agents do. ITI-007 significantly and dose-dependently increased the percent of SWS early in the night (p=0.022 for the first quarter of the night, p=0.029 for the second quarter of the night). Late in the night, towards morning, ITI-007 increased the percent of Stage 2 sleep (p=0.048 for the third quarter of the night, p=0.004 for the fourth quarter of the night). ITI-007 did not affect total duration of REM sleep (p=0.124) and ITI-007 did not affect latency to the first episode of REM (p=0.143). As predicted by its mechanism, ITI-007 did not affect latency to persistent sleep (p=0.455). Overall, the increases in SWS and Stage 2 sleep came at the expense of decreased percent time spent awake or drowsy (Stage 1 sleep, p<0.001). This was especially reflected by the ability of ITI-007 to decrease percent time spent awake or drowsy in the fourth quarter of the night compared to placebo (p=0.002), a time when other hypnotics tend to cause rebound increases in early morning wakefulness.

PHASE II RESULTS FOR ITI-007

                                                                  Dose-
                                                                Response
                                                                  Trend
    Polysomnography                                             Analysis
    Outcome Measure      Mean Change from Baseline (min)         p-value
                                             ITI-007
                       Placebo      1 mg      5 mg     10 mg

    SWS  
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SOURCE Intra-Cellular Therapies, Inc.
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