IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00281320
First received: January 23, 2006
Last updated: February 20, 2015
Last verified: February 2015
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 Intervention Model: Parallel Assignment Masking: Double Blind (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. |
Resource links provided by NLM:
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) ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 (Adult, Senior) |
| 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
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
No Contacts or Locations Provided
More Information
Publications:
| 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: | February 20, 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 |
ClinicalTrials.gov processed this record on July 19, 2017