Schizophrenia
Conditions
Keywords
schizophrenia, asenapine, Once daily, twice daily
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: 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
Interventions
DRUGAsenapine 10 mg daily in the evening
The total daily dose of Asenapine will be given once daily in the evening
DRUGAsenapine 5 mg twice daily
Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily
Sponsors
Merck Sharp & Dohme LLC
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Acceptance | At day 14 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Brief Psychiatric Rating Scale (BPRS) Total Score | From baseline to day 14 | 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 |
Countries
United States
Participant flow
Recruitment details
30 PATIENTS PARTICIPATED AND WERE RANDOMIZED 12 WERE RANDOMIZED TO ASENAPINE 10 MG QHS 18 WERE RANTOMIZED TO ASENAPINE 5 MG BID
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| 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 | 18 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 4 |
| Overall Study | Lack of Efficacy | 2 | 4 |
Baseline characteristics
| Characteristic | Asenapine 10 mg Daily in the Evening | Total | Asenapine 5 mg Twice Daily |
|---|---|---|---|
| Age, Continuous age | 41.2 years | 36.3 years | 33.1 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 24 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 5 Participants | 4 Participants |
| Region of Enrollment United States | 12 participants | 30 participants | 18 participants |
| Sex: Female, Male Female | 7 Participants | 17 Participants | 10 Participants |
| Sex: Female, Male Male | 5 Participants | 13 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 4 / 18 |
| serious Total, serious adverse events | 0 / 12 | 0 / 18 |
Outcome results
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.
Time frame: At day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asenapine 10 mg Daily in the Evening | Patient Acceptance | 1.7 units on a scale | Standard Error 0.5 |
| Asenapine 5 mg Twice Daily | Patient Acceptance | 3.9 units on a scale | Standard Error 0.5 |
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
Time frame: From baseline to day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asenapine 10 mg Daily in the Evening | Change in Brief Psychiatric Rating Scale (BPRS) Total Score | 16.08 units on a scale | Standard Error 2.64 |
| Asenapine 5 mg Twice Daily | Change in Brief Psychiatric Rating Scale (BPRS) Total Score | 7.72 units on a scale | Standard Error 2.21 |