Once-Daily Asenapine for Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Duke University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01549041
First received: October 14, 2011
Last updated: March 6, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: Asenapine 10 mg once daily in the evening
Drug: Asenapine 5 mg twice daily
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Twice-Daily Versus Once-Daily Asenapine for Schizophrenia

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Patient acceptance [ Time Frame: At day 14 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change in Brief Psychiatric Rating Scale (BPRS) total score [ Time Frame: From baseline to day 14 ] [ Designated as safety issue: No ]
    The BPRS will be completed by the Principle Investigator at baseline and at day 14. The BPRS has 18 items each rated 1-7; thus the highest and lowest possible scores are 18 and 126

  • Staff acceptance [ Time Frame: At day 14 ] [ Designated as safety issue: No ]
    A Staff Acceptance Likert Scale (1= Very Acceptable to 7 = Completely Unacceptable) will be administered to the ward Medication Nurse by the Research Nurse on day 14 of treatment


Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 once daily in the evening
The total daily dose of Asenapine will be given once daily in the evening
Other Name: 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 Name: Saphris

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549041

Contacts
Contact: Joseph P McEvoy, MD 919-819-9295 jpmcevoy@duke.edu
Contact: William H Wilson, PhD 919-575-7360 wilso066@mc.duke.edu

Locations
United States, North Carolina
Central Regional Hospital Not yet recruiting
Butner, North Carolina, United States, 27609
Contact: Joseph P McEvoy, MD    919-819-9295    jpmcevoy@duke.edu   
Contact: William H Wilson, PhD    919-575-7360    wilso066@mc.duke.edu   
Principal Investigator: Joseph P McEvoy, MD         
Sponsors and Collaborators
Duke University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Joseph P McEvoy, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01549041     History of Changes
Other Study ID Numbers: Pro00029068
Study First Received: October 14, 2011
Last Updated: March 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
schizophrenia
asenapine
Once daily
twice daily

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Asenapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 16, 2014