Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)

Primary outcomes

1. Number of Participants Who Experienced an Adverse Event

   Time frame: Up to Day 42 (treatment period)

   Participants who experienced treatment-emergent adverse events, defined as newly reported events after baseline or events reported to have worsened in severity since baseline (from the date of informed consent to the last dose day + 7 days for non-serious adverse events and 30 days for serious adverse events).

2. Number of Participants Who Discontinued Because of an Adverse Event

   Time frame: up to 30 days after study medication stop date

   Discontinuations due to treatment-emergent adverse events starting on or after Day1 and up to 7 days after study medication stop date (30 days for serious adverse events).

3. Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax

   Time frame: Day 4 or 8

   Tmax defined as time to peak concentration.

4. Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax

   Time frame: Day 4 or 8

   Cmax defined as peak concentration.

5. Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax

   Time frame: Day 4 or 8

   dn-Cmax is defined as dose normalized peak concentration.

6. Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin

   Time frame: Day 4 or 8

   Cmin defined as pre-dose concentration.

7. Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12

   Time frame: Day 4 or 8

   AUC 0-12 defined as area-under-the-curve from zero to time point 12 hours.

8. Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12

   Time frame: Day 4 or 8

   dn-AUC 0-12 defined as dose-normalized area-under-the-curve from zero to time point 12 hours.