Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)
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ClinicalTrials.gov Identifier: NCT00281320 |
Recruitment Status :
Completed
First Posted : January 24, 2006
Results First Posted : September 9, 2010
Last Update Posted : February 9, 2022
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Sponsor:
Organon and Co
Information provided by (Responsible Party):
Organon and Co
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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 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 |
Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics:
Schizophrenia
Arm | Intervention/treatment |
---|---|
Experimental: Asenapine 2-10 mg BID
Dose titration from 2 mg to 5 mg to 10 mg twice daily (BID)
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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 |
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.
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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
No Contacts or Locations Provided
Publications of Results:
Responsible Party: | Organon and Co |
ClinicalTrials.gov Identifier: | NCT00281320 |
Other Study ID Numbers: |
P05717 A7501021 |
First Posted: | January 24, 2006 Key Record Dates |
Results First Posted: | September 9, 2010 |
Last Update Posted: | February 9, 2022 |
Last Verified: | February 2022 |
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 |