Once-Daily Asenapine for Schizophrenia

A Randomized Comparison of Twice-Daily Versus Once-Daily Asenapine for Schizophrenia

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Asenapine 10 mg daily in the evening; Drug: Asenapine 5 mg twice daily

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Butner, North Carolina, United States, 27609
      • Central Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: asenapine 10 mg daily in the evening; Patients will receive their entire daily dose of asenapine as a single dose in the evening	Drug: Asenapine 10 mg daily in the evening; The total daily dose of Asenapine will be given once daily in the evening; Other Names: Saphris
Active Comparator: asenapine 5 mg twice daily; Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening	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; Other Names: Saphris

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: John Beyer, MD, Duke University

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: October 14, 2011
• First Submitted That Met QC Criteria: March 6, 2012
• First Posted (Estimate): March 8, 2012

Study Record Updates

• Last Update Posted (Estimate): May 26, 2014
• Last Update Submitted That Met QC Criteria: April 23, 2014
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: schizophrenia; twice daily; asenapine; Once daily
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Asenapine
• Other Study ID Numbers: Pro00029068