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

Phase 3

Completed

• Conditions: Psychosis
• Interventions: Drug: Asenapine

• Registration Number: NCT00281320
• Lead Sponsor: Organon and Co

Brief Summary

This study evaluates the safety and tolerability of Asenapine in elderly patients with psychosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-01-23
• Study First Submitted QC: 2006-01-23
• Study First Posted: 2006-01-24
• Study Start: 2006-02
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Disposition First Submitted: 2009-04-17
• Disposition First Submitted QC: 2009-10-02
• Disposition First Posted: 2009-10-06
• Results First Submitted: 2010-08-12
• Results First Submitted QC: 2010-08-12
• Results First Posted: 2010-09-09
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• Elderly subjects with psychosis

Exclusion Criteria

• Have an uncontrolled, unstable clinically significant

medical condition.

• Have an established diagnosis of dementia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Asenapine 2-10 mg BID	Asenapine	Dose titration from 2 mg to 5 mg to 10 mg twice daily (BID)
Asenapine 5-10mg BID	Asenapine	Dose titration from 5 mg to 10 mg BID

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Discontinued Because of an Adverse Event	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).
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin	Day 4 or 8	Cmin defined as pre-dose concentration.
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax	Day 4 or 8	Tmax defined as time to peak concentration.
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax	Day 4 or 8	Cmax defined as peak concentration.
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12	Day 4 or 8	AUC 0-12 defined as area-under-the-curve from zero to time point 12 hours.
Number of Participants Who Experienced an Adverse Event	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).
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax	Day 4 or 8	dn-Cmax is defined as dose normalized peak concentration.
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12	Day 4 or 8	dn-AUC 0-12 defined as dose-normalized area-under-the-curve from zero to time point 12 hours.