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

Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00281320
• Other study ID #: P05717
• Secondary ID: A7501021
• Status: Completed
• Phase: Phase 3
• Start date: February 2006
• Est. completion date: December 2008

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Elderly subjects with psychosis

Exclusion Criteria:

• Have an uncontrolled, unstable clinically significant

medical condition.

• Have an established diagnosis of dementia

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Drug:
• Asenapine
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Dubovsky SL, Frobose C, Phiri P, de Greef R, Panagides J. Short-term safety and pharmacokinetic profile of asenapine in older patients with psychosis. Int J Geriatr Psychiatry. 2012 May;27(5):472-82. doi: 10.1002/gps.2737. Epub 2011 Jul 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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