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OpenTrials
Completed

NCT Number: NCT01549041

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Central Regional Hospital

Butner, North Carolina, 27609, United States

About this study

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:

  • 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
  • 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
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Asenapine 10 mg daily in the evening

Drug

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

Other names: Saphris

Asenapine 5 mg twice daily

Drug

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

Other names: Saphris

Primary outcomes

  1. Patient Acceptance

    Time frame: 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 outcomes

  1. Change in Brief Psychiatric Rating Scale (BPRS) Total Score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 8, 2012
Registry last updated
May 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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