This study evaluates the safety and tolerability of Asenapine in elderly patients with psychosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
122
Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6); or Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6).
Number of Participants Who Experienced an Adverse Event
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).
Time frame: Up to Day 42 (treatment period)
Number of Participants Who Discontinued Because of an Adverse Event
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).
Time frame: up to 30 days after study medication stop date
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax
Tmax defined as time to peak concentration.
Time frame: Day 4 or 8
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax
Cmax defined as peak concentration.
Time frame: Day 4 or 8
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax
dn-Cmax is defined as dose normalized peak concentration.
Time frame: Day 4 or 8
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin
Cmin defined as pre-dose concentration.
Time frame: Day 4 or 8
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12
AUC 0-12 defined as area-under-the-curve from zero to time point 12 hours.
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Time frame: Day 4 or 8
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12
dn-AUC 0-12 defined as dose-normalized area-under-the-curve from zero to time point 12 hours.
Time frame: Day 4 or 8