At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 120 enrolled
Drug / intervention
Asenapine +1 moredrug
Likely dose
Asenapine 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treating Acutely Agitated Patients With Asenapine Sublingual Tablets: A Single-Dose, Randomized, Double-Blind Placebo Controlled Trial
In Brief
A Phase 4 clinical trial evaluating Asenapine and Placebo for Agitation. Completed, enrolled 120 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAgitation
CountriesUnited States
CollaboratorsSchering-Plough
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 2011
Enrollment StartApr 2012
Primary CompletionDec 2012
TodayJul 2026
First PostedJul 22, 2011
Enrollment StartApr 1, 2012
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.9 years ago
Interventions
Asenapinedrug
Asenapine Sublingual Tablet 10mg, single-dose
Placebodrug
Placebo Sublingual Tablet, single-dose