CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Asenapine 10 mg daily in the evening +1 moredrug
Likely dose
Asenapine 10 mg daily in the eveningfrom 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.

Search/NCT01549041
NCT01549041Phase 4Completed

A Randomized Comparison of Twice-Daily Versus Once-Daily Asenapine for Schizophrenia

Duke University·interventional·Posted Mar 8, 2012·Updated May 26, 2014

In Brief

A Phase 4 clinical trial evaluating Asenapine 10 mg daily in the evening and Asenapine 5 mg twice daily for Schizophrenia. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The investigators propose to explore: 1. the acceptance by patients of once versus twice daily dosing with asenapine, 2. the acceptance by staff of once versus twice daily dosing with asenapine, and 3. the changes in psychopathology associated with these two dosing strategies, in 30 patients with schizophrenia or schizoaffective disorder. The investigators hypothesize that patient and staff acceptance will be better with once daily dosing and that improvements in psychopathology will be similar across once daily and twice daily dosing

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 8, 2012
Enrollment StartApr 1, 2012
Primary CompletionApr 1, 2013
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 14.3 years ago

Interventions

Asenapine 10 mg daily in the eveningdrug

The total daily dose of Asenapine will be given once daily in the evening

Asenapine 5 mg twice dailydrug

Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily