Once-Daily Asenapine for Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549041
• Other study ID #: Pro00029068
• Status: Completed
• Phase: Phase 4
• First received: October 14, 2011
• Last updated: April 23, 2014
• Start date: April 2012
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Asenapine 10 mg daily in the evening
The total daily dose of Asenapine will be given once daily in the evening
• Asenapine 5 mg twice daily
Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily

Locations

Country	Name	City	State
United States	Central Regional Hospital	Butner	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Acceptance	A Patient Acceptance Likert Scale (1= Very Acceptable to 7 = Completely Unacceptable, i.e., individual refuses further doses) will be administered to the patient by the Research Nurse on day 14 of treatment.	At day 14	No
Secondary	Change in Brief Psychiatric Rating Scale (BPRS) Total Score	The BPRS will be completed by the Principle Investigator at baseline and at day 14. The BPRS has 18 items each rated 1-7 with 1 representing the lowest severity of symptoms and 7 representing the highest severity; thus the lowest and highest possible total scores are 18 and 126	From baseline to day 14	No