Once-Daily Asenapine for Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Asenapine 10 mg daily in the evening
Asenapine 5 mg twice daily
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, asenapine, Once daily, twice daily
Eligibility 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
Sites / Locations
- Central Regional Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
asenapine 10 mg daily in the evening
asenapine 5 mg twice daily
Arm Description
Patients will receive their entire daily dose of asenapine as a single dose in the evening
Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01549041
First Posted
October 14, 2011
Last Updated
April 23, 2014
Sponsor
Duke University
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01549041
Brief Title
Once-Daily Asenapine for Schizophrenia
Official Title
A Randomized Comparison of Twice-Daily Versus Once-Daily Asenapine for Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
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:
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
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, asenapine, Once daily, twice daily
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
asenapine 10 mg daily in the evening
Arm Type
Experimental
Arm Description
Patients will receive their entire daily dose of asenapine as a single dose in the evening
Arm Title
asenapine 5 mg twice daily
Arm Type
Active Comparator
Arm Description
Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening
Intervention Type
Drug
Intervention Name(s)
Asenapine 10 mg daily in the evening
Other Intervention Name(s)
Saphris
Intervention Description
The total daily dose of Asenapine will be given once daily in the evening
Intervention Type
Drug
Intervention Name(s)
Asenapine 5 mg twice daily
Other Intervention Name(s)
Saphris
Intervention Description
Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily
Primary Outcome Measure Information:
Title
Patient Acceptance
Description
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.
Time Frame
At day 14
Secondary Outcome Measure Information:
Title
Change in Brief Psychiatric Rating Scale (BPRS) Total Score
Description
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
Time Frame
From baseline to day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Beyer, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Regional Hospital
City
Butner
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Once-Daily Asenapine for Schizophrenia
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