Once-Daily Asenapine for Schizophrenia

NCT ID: NCT01549041

Last Updated: 2014-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-11-30

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

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

asenapine 10 mg daily in the evening

Patients will receive their entire daily dose of asenapine as a single dose in the evening

Group Type: EXPERIMENTAL

Asenapine 10 mg daily in the evening

Intervention Type: DRUG

The total daily dose of Asenapine will be given once daily in the evening

asenapine 5 mg twice daily

Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening

Group Type: ACTIVE_COMPARATOR

Asenapine 5 mg twice daily

Intervention Type: DRUG

Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily

Interventions

Asenapine 10 mg daily in the evening

The total daily dose of Asenapine will be given once daily in the evening

Intervention Type: DRUG

Asenapine 5 mg twice daily

Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily

Intervention Type: DRUG

Other Intervention Names

Saphris; Saphris

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Beyer, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Central Regional Hospital

Butner, North Carolina, United States

Countries

United States

Other Identifiers

Pro00029068

Identifier Type: -

Identifier Source: org_study_id