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NCT01460290 · ClinicalTrials.gov registry record · Phase 4
Asenapine in the Treatment of Older Adults With Bipolar Disorder
A Phase 4 study, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT01460290: Completed Phase 4 study, sponsored by University Hospitals Cleveland Medical Center.
NCT01460290 is a Phase 4 study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 15 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01460290, a Phase 4 study, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study Summary
Objectives: The investigators propose a first-ever, prospective trial of asenapine in older adults with bipolar disorder (BD) to evaluate effects on mood symptoms, tolerability and functional/general health status. Given the dearth of treatment data on older adults with BD, findings are likely to be of substantial clinical interest, may inform larger future studies and will assist in refining bipolar treatment recommendations. Hypotheses: Primary: Asenapine therapy will be associated with reduced bipolar manic and depressive symptoms in older adults with BD. Secondary: Asenapine therapy will be associated with improved functional and general health status, improved global psychopathology, and good tolerability in older adults with BD.
Primary Outcome
The minimum possible score is 0 and the maximum score is 52. A higher score implies a worse condition.
Interventions
- DRUG Asenapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2011-10 |
| Est. Completion | 2014-03 |
| Phase | Phase 4 |
What the finished NCT01460290 record still lists
NCT01460290 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Asenapine is the first listed.
NCT01460290 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01460290 about?
NCT01460290 is a clinical study titled "Asenapine in the Treatment of Older Adults With Bipolar Disorder". Objectives: The investigators propose a first-ever, prospective trial of asenapine in older adults with bipolar disorder (BD) to evaluate effects on mood symptoms, tolerability and functional/general health status. Given the dearth of treatment data on older adults with BD, findings are likely to be...
What is the current status of trial NCT01460290?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2011-10. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01460290?
The interventions under investigation include: Asenapine (DRUG).
Who is sponsoring clinical trial NCT01460290?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01460290's enrollment target sits among peer trials
15 1880th of 2000 higher than 100 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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