Clinical trial NCT01549041: Once-Daily Asenapine for Schizophrenia
Official title: A Randomized Comparison of Twice-Daily Versus Once-Daily Asenapine for Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: schizophrenia
asenapine
Once daily
twice daily
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2012-03-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Patient Acceptance
timeFrame: At day 14
Secondary outcomes:
measure: Change in Brief Psychiatric Rating Scale (BPRS) Total Score
timeFrame: From baseline to day 14
Other outcomes:
Locations:
city: Butner
country: United States
facility: Central Regional Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: John Beyer, MD
role: PRINCIPAL_INVESTIGATOR
References: