Once-Daily Asenapine for Schizophrenia

NCT01549041 | Completed Phase 4 Results

• 1 other identifier: Pro00029068
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Schizophrenia

Keywords

schizophrenia; asenapine; Once daily; twice daily

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Brief Psychiatric Rating Scale (BPRS) Total Score

  From baseline to day 14

Study Arms (2)

asenapine 10 mg daily in the evening

EXPERIMENTAL

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

Drug: Asenapine 10 mg daily in the evening

asenapine 5 mg twice daily

ACTIVE COMPARATOR

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

Drug: Asenapine 5 mg twice daily

Interventions

Asenapine 10 mg daily in the evening DRUG

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

Also known as: Saphris

asenapine 10 mg daily in the evening

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

Also known as: Saphris

asenapine 5 mg twice daily

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female individuals,
• 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.

You may not qualify if:

• Females who are lactating or pregnant,
• individuals with a prior history of poor therapeutic response or sensitivity to asenapine, will be excluded

Sponsors & Collaborators

• Duke University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Central Regional Hospital

Butner, North Carolina, 27609, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

asenapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Limitations and Caveats

Small sample size Open label design

Results Point of Contact

• Title: Joseph P McEvoy, MD
• Organization: DukeUMC

JPMCEVOY@DUKE.EDU

9198199295

Study Officials

• John Beyer, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2011
• First Posted: March 8, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: November 1, 2013
• Last Updated: May 26, 2014
• Results First Posted: May 26, 2014

Record last verified: 2013-11

Locations

US (1)