Once-Daily Asenapine for Schizophrenia

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01549041
• Collaborator: Merck Sharp & Dohme LLC (Industry)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Asenapine 10 mg daily in the evening; Drug: Asenapine 5 mg twice daily	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Comparison of Twice-Daily Versus Once-Daily Asenapine for Schizophrenia
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Patient Acceptance [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 Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Central Regional Hospital	Butner	North Carolina	United States	27609

Sponsors and Collaborators

• Duke University
• Merck Sharp & Dohme LLC

Investigators

• Principal Investigator: John Beyer, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT01549041
• Other Study ID Numbers: Pro00029068
• First Posted: Mar 8, 2012
• Last Update Posted: May 26, 2014
• Last Verified: Nov 1, 2013

• Keywords provided by Duke University: schizophrenia; asenapine; Once daily; twice daily
• Additional relevant MeSH terms: Schizophrenia; Asenapine

Study Results

Participant Flow

Recruitment Details	30 PATIENTS PARTICIPATED AND WERE RANDOMIZED 12 WERE RANDOMIZED TO ASENAPINE 10 MG QHS 18 WERE RANTOMIZED TO ASENAPINE 5 MG BID

Arm/Group Title	Asenapine 10 mg Daily in the Evening	Asenapine 5 mg Twice Daily
Arm/Group Description	Patients will receive their entire daily dose of asenapine as a single dose in the evening Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening	Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily
Period Title: Overall Study
STARTED	12	18
COMPLETED	10	10
NOT COMPLETED	2	8

Baseline Characteristics

Arm/Group Title	Asenapine 10 mg Daily in the Evening	Asenapine 5 mg Twice Daily	Total
Arm/Group Description	Patients will receive their entire daily dose of asenapine as a single dose in the evening Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening	Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily	Total of all reporting groups
Overall Participants	12	18	30
Age (years) [Mean (Full Range) ]
age	41.2	33.1	36.3
Sex: Female, Male (Count of Participants)
Female	7 58.3%	10 55.6%	17 56.7%
Male	5 41.7%	8 44.4%	13 43.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 8.3%	0 0%	1 3.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	10 83.3%	14 77.8%	24 80%
White	1 8.3%	4 22.2%	5 16.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	12 100%	18 100%	30 100%

Outcome Measures

1. Primary Outcome

Title	Patient Acceptance
Description	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.
Time Frame	At day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Asenapine 10 mg Daily in the Evening	Asenapine 5 mg Twice Daily
Arm/Group Description	Patients will receive their entire daily dose of asenapine as a single dose in the evening Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening	Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily
Measure Participants	12	18
Mean (Standard Error) [units on a scale]	1.7 (0.5)	3.9 (0.5)

2. Secondary Outcome

Title	Change in Brief Psychiatric Rating Scale (BPRS) Total Score
Description	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
Time Frame	From baseline to day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Asenapine 10 mg Daily in the Evening	Asenapine 5 mg Twice Daily
Arm/Group Description	Patients will receive their entire daily dose of asenapine as a single dose in the evening Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening	Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily
Measure Participants	12	18
Mean (Standard Error) [units on a scale]	16.08 (2.64)	7.72 (2.21)

Adverse Events

Arm/Group Title	Asenapine 10 mg Daily in the Evening		Asenapine 5 mg Twice Daily
Arm/Group Description	Patients will receive their entire daily dose of asenapine as a single dose in the evening Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening		Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily
All Cause Mortality
	Asenapine 10 mg Daily in the Evening		Asenapine 5 mg Twice Daily
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Asenapine 10 mg Daily in the Evening		Asenapine 5 mg Twice Daily
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Asenapine 10 mg Daily in the Evening		Asenapine 5 mg Twice Daily
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		4/18 (22.2%)
Nervous system disorders
daytime drowsiness	0/12 (0%)	0	4/18 (22.2%)	4

Limitations/Caveats

Small sample size Open label design

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.