Once-Daily Asenapine for Schizophrenia

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Asenapine

Criteria

Inclusion Criteria:

• Male or female individuals,

• 18-65 years of age,

• who meet DSM-IV diagnostic criteria for schizophrenia or schizoaffective disorder,

• who are newly admitted to Central Regional Hospital for treatment of an acute psychotic exacerbation,

• who provide signed informed consent to participate, will be included.

Exclusion Criteria:

• Females who are lactating or pregnant,

• individuals with a prior history of poor therapeutic response or sensitivity to asenapine, will be excluded