Trial Outcomes & Findings for Once-Daily Asenapine for Schizophrenia (NCT NCT01549041)
NCT ID: NCT01549041
Last Updated: 2014-05-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
At day 14
Results posted on
2014-05-26
Participant Flow
30 PATIENTS PARTICIPATED AND WERE RANDOMIZED 12 WERE RANDOMIZED TO ASENAPINE 10 MG QHS 18 WERE RANTOMIZED TO ASENAPINE 5 MG BID
Participant milestones
| Measure |
Asenapine 10 mg Daily in the Evening
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
|
Asenapine 5 mg Twice Daily
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
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
18
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
8
|
Reasons for withdrawal
| Measure |
Asenapine 10 mg Daily in the Evening
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
|
Asenapine 5 mg Twice Daily
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
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
4
|
|
Overall Study
Adverse Event
|
0
|
4
|
Baseline Characteristics
Once-Daily Asenapine for Schizophrenia
Baseline characteristics by cohort
| Measure |
Asenapine 10 mg Daily in the Evening
n=12 Participants
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
|
Asenapine 5 mg Twice Daily
n=18 Participants
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
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
age
|
41.2 years
n=5 Participants
|
33.1 years
n=7 Participants
|
36.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
18 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At day 14A 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.
Outcome measures
| Measure |
Asenapine 10 mg Daily in the Evening
n=12 Participants
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
|
Asenapine 5 mg Twice Daily
n=18 Participants
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
|
|---|---|---|
|
Patient Acceptance
|
1.7 units on a scale
Standard Error 0.5
|
3.9 units on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: From baseline to day 14The 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
Outcome measures
| Measure |
Asenapine 10 mg Daily in the Evening
n=12 Participants
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
|
Asenapine 5 mg Twice Daily
n=18 Participants
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
|
|---|---|---|
|
Change in Brief Psychiatric Rating Scale (BPRS) Total Score
|
16.08 units on a scale
Standard Error 2.64
|
7.72 units on a scale
Standard Error 2.21
|
Adverse Events
Asenapine 10 mg Daily in the Evening
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Asenapine 5 mg Twice Daily
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Asenapine 10 mg Daily in the Evening
n=12 participants at risk
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
|
Asenapine 5 mg Twice Daily
n=18 participants at risk
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
|
|---|---|---|
|
Nervous system disorders
daytime drowsiness
|
0.00%
0/12
|
22.2%
4/18 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place