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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 is a Phase 4 study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 15 participants.
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.
Interventions
- DRUG Asenapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2011-10 |
| Est. Completion | 2014-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01460290
The ClinicalTrials.gov registry entry for NCT01460290 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Asenapine is the first listed.
NCT01460290 reports 0 study locations.
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.
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