Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717) - Full Text View

Purpose

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

Condition	Intervention	Phase
Psychosis	Drug: Asenapine	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

MedlinePlus related topics: Mental Disorders Psychotic Disorders

Drug Information available for: Asenapine

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

Number of Participants Who Experienced an Adverse Event [ Time Frame: Up to Day 42 (treatment period) ] [ Designated as safety issue: Yes ]
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).
Number of Participants Who Discontinued Because of an Adverse Event [ Time Frame: up to 30 days after study medication stop date ] [ Designated as safety issue: Yes ]
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, Tmax [ Time Frame: Day 4 or 8 ] [ Designated as safety issue: No ]
Tmax defined as time to peak concentration.
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax [ Time Frame: Day 4 or 8 ] [ Designated as safety issue: No ]
Cmax defined as peak concentration.
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax [ Time Frame: Day 4 or 8 ] [ Designated as safety issue: No ]
dn-Cmax is defined as dose normalized peak concentration.
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin [ Time Frame: Day 4 or 8 ] [ Designated as safety issue: No ]
Cmin defined as pre-dose concentration.
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12 [ Time Frame: Day 4 or 8 ] [ Designated as safety issue: No ]
AUC 0-12 defined as area-under-the-curve from zero to time point 12 hours.
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 ] [ Designated as safety issue: No ]
dn-AUC 0-12 defined as dose-normalized area-under-the-curve from zero to time point 12 hours.


Enrollment:	122
Study Start Date:	February 2006
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

Publications:

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 History of Changes
Other Study ID Numbers:	P05717, A7501021
Study First Received:	January 23, 2006
Results First Received:	August 12, 2010
Last Updated:	January 14, 2015
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features Asenapine Antipsychotic Agents Central Nervous System Agents	Central Nervous System Depressants Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Therapeutic Uses Tranquilizing Agents

ClinicalTrials.gov processed this record on February 27, 2015