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

• ClinicalTrials.gov Identifier: NCT00281320
• Recruitment Status: Completed
• First Posted: January 24, 2006
• Results First Posted: September 9, 2010
• Last Update Posted: March 10, 2015
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Psychosis	Drug: Asenapine	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Parallel Group, Multiple Dose, 6-Week Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Asenapine in Elderly Subjects With Psychosis.
• Study Start Date: February 2006
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: December 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Asenapine 2-10 mg BID; Dose titration from 2 mg to 5 mg to 10 mg twice daily (BID)	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).; Other Name: Saphris
Experimental: Asenapine 5-10mg BID; Dose titration from 5 mg to 10 mg BID	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).; Other Name: Saphris

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Elderly subjects with psychosis

Exclusion Criteria:

• Have an uncontrolled, unstable clinically significant

medical condition.

• Have an established diagnosis of dementia

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications of Results:

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.

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT00281320
• Other Study ID Numbers: P05717; A7501021
• First Posted: January 24, 2006
• Results First Posted: September 9, 2010
• Last Update Posted: March 10, 2015
• Last Verified: February 2015

Additional relevant MeSH terms:

Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Asenapine; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Psychotropic Drugs