Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| asenapine 10 mg daily in the evening | Experimental | Patients will receive their entire daily dose of asenapine as a single dose in the evening |
|
| asenapine 5 mg twice daily | Active Comparator | Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asenapine 10 mg daily in the evening | Drug | The total daily dose of Asenapine will be given once daily in the evening |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John Beyer, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Regional Hospital | Butner | North Carolina | 27609 | United States |
Not provided
30 PATIENTS PARTICIPATED AND WERE RANDOMIZED 12 WERE RANDOMIZED TO ASENAPINE 10 MG QHS 18 WERE RANTOMIZED TO ASENAPINE 5 MG BID
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Asenapine 10 mg Daily in the Evening | Patients will receive their entire daily dose of asenapine as a single dose in the evening Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening |
| FG001 | Asenapine 5 mg Twice Daily | Patients will receive asenapine 5 mg daily in the morning and 5 mg 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Asenapine 10 mg Daily in the Evening | Patients will receive their entire daily dose of asenapine as a single dose in the evening Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening |
| BG001 | Asenapine 5 mg Twice Daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | units on a scale | At day 14 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Asenapine 10 mg Daily in the Evening | Patients will receive their entire daily dose of asenapine as a single dose in the evening Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| daytime drowsiness | Nervous system disorders | Systematic Assessment | excessive sedation during the day |
Small sample size Open label design
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph P McEvoy, MD | DukeUMC | 9198199295 | JPMCEVOY@DUKE.EDU |
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C522667 | asenapine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Asenapine 5 mg twice daily | Drug | Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily |
|
|
Patients will receive asenapine 5 mg daily in the morning and 5 mg 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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 | Posted | Mean | Standard Error | units on a scale | From baseline to day 14 |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Asenapine 5 mg Twice Daily | Patients will receive asenapine 5 mg daily in the morning and 5 mg 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 | 0 | 18 | 4 | 18 |
|
Not provided
Not provided