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Once-Daily Asenapine for Schizophrenia

NCT01549041 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-05-26

Study results available
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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

Conditions

Interventions

DRUG

Asenapine 10 mg daily in the evening

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

DRUG

Asenapine 5 mg twice daily

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

Sponsors & Collaborators

Principal Investigators

  • John Beyer, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-04-30
Completion
2013-11-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01549041 on ClinicalTrials.gov