Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)
NCT ID: NCT00281320
Last Updated: 2022-02-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
122 participants
INTERVENTIONAL
2006-02-28
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Asenapine 2-10 mg BID
Dose titration from 2 mg to 5 mg to 10 mg twice daily (BID)
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).
Asenapine 5-10mg BID
Dose titration from 5 mg to 10 mg BID
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).
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
medical condition.
* Have an established diagnosis of dementia
65 Years
ALL
No
Sponsors
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Organon and Co
INDUSTRY
Responsible Party
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References
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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.
Other Identifiers
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A7501021
Identifier Type: -
Identifier Source: secondary_id
P05717
Identifier Type: -
Identifier Source: org_study_id
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