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NCT01400113 · ClinicalTrials.gov registry record · Phase 4
Treating Acutely Agitated Patients With Asenapine Sublingual Tablets
A Phase 4 study, sponsored by Unity Health Toronto.
- Completed
- Registry status
- Phase 4
- Development phase
- 120
- Enrollment target
NCT01400113: Completed Phase 4 study, sponsored by Unity Health Toronto.
NCT01400113 is a Phase 4 study that has completed, run by Unity Health Toronto. The registered enrollment target is 120 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01400113, a Phase 4 study, has completed, sponsored by Unity Health Toronto.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 120 participants
- Enrollment target
Study Summary
Our proposal is to administer asenapine to patients who are clinically agitated and in need of immediate intervention. At present there are no controlled studies that we know of that explores the use of asenapine for this purpose. Establishing the utility of asenapine for this common clinical problem will support its use as an additional treatment option in acutely agitated patients.
Primary Outcome
The primary outcome measure is change in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) from baseline to 2 hours after medication administration. The PANSS-EC consists of 5 items: excitement, tension, hostility, uncooperativeness, and poor impulse control. The 5 items from the PANSS-EC are rated from 1 (not present) to 7 (extremely severe); scores range from 5 to 35; mean scores ≥ 20 clinically correspond to severe agitation. This set of items detects differences between
Interventions
- DRUG Placebo
- DRUG Asenapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2012-04 |
| Est. Completion | 2012-12 |
| Phase | Phase 4 |
What the finished NCT01400113 record still lists
NCT01400113 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01400113 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01400113 about?
NCT01400113 is a clinical study titled "Treating Acutely Agitated Patients With Asenapine Sublingual Tablets". Our proposal is to administer asenapine to patients who are clinically agitated and in need of immediate intervention. At present there are no controlled studies that we know of that explores the use of asenapine for this purpose. Establishing the utility of asenapine for this common clinical proble...
What is the current status of trial NCT01400113?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2012-04. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01400113?
The interventions under investigation include: Placebo (DRUG), Asenapine (DRUG).
Who is sponsoring clinical trial NCT01400113?
This trial is sponsored by Unity Health Toronto, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01400113's enrollment target sits among peer trials
120 673rd of 2000 higher than 1,289 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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