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Once-Daily Asenapine for Schizophrenia

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Asenapine 10 mg daily in the evening (Drug); Asenapine 5 mg twice daily (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
John Beyer, MD, Principal Investigator, Affiliation: Duke University

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Patient Acceptance

Secondary outcome: Change in Brief Psychiatric Rating Scale (BPRS) Total Score

Detailed description: The investigators will randomly assign 30 patients newly admitted to Central Regional Hospital (CRH) for a psychotic exacerbation of schizophrenia or schizo-affective disorder to 14 days of treatment with either asenapine 5 mg BID or asenapine 10 mg QHS. The investigators will assess patient and staff acceptance on day 14. The investigators will assess staff acceptance on day 14. The investigators will assess changes in psychopathology (Brief Psychiatric Rating Scale) from baseline to day 14. The investigators propose to achieve the following specific aims: 1. To compare the patient acceptance of once daily versus twice daily asenapine; The investigators hypothesize that patient acceptance will be better for asenapine 10 mg QHS than for asenapine 5 mg BID at day 14 2. To compare the staff (medication nurses) acceptance of once daily versus twice daily asenapine; the investigators hypothesize that staff acceptance will be better for asenapine 10 mg QHS than for asenapine 5 mg BID at day 14 3. To compare the changes in psychopathology with once daily versus twice daily asenapine; the investigators hypothesize that changes in psychopathology from baseline to day 14 will be similar for the two dosing strategies

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Central Regional Hospital, Butner, North Carolina 27609, United States
Additional Information

Starting date: April 2012
Last updated: April 23, 2014

Page last updated: August 23, 2015

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