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

Study Overview
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Brief Summary
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This study evaluates the safety and tolerability of Asenapine in elderly patients with psychosis.

Official Title
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A Randomized, Parallel Group, Multiple Dose, 6-Week Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Asenapine in Elderly Subjects With Psychosis.

Conditions
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Psychosis

Intervention / Treatment
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* Drug: Asenapine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elderly subjects with psychosis Exclusion Criteria: Have an uncontrolled, unstable clinically significant medical condition. Have an established diagnosis of dementia

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Asenapine 2-10 mg BID<br>Dose titration from 2 mg to 5 mg to 10 mg twice daily (BID) | Drug: Asenapine<br>* 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).<br>* Other names: Saphris;|
| Experimental: Asenapine 5-10mg BID<br>Dose titration from 5 mg to 10 mg BID | Drug: Asenapine<br>* 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).<br>* Other names: Saphris;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | Day 4 or 8 |