Trial Outcomes & Findings for A Study of the Efficacy and Safety of Asenapine in Participants With an Acute Exacerbation of Schizophrenia (P05688) (NCT NCT01617187)
NCT ID: NCT01617187
Last Updated: 2024-06-18
Results Overview
The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 42; improvement in symptoms is represented by negative values.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
360 participants
Primary outcome timeframe
Baseline and Day 42
Results posted on
2024-06-18
Participant Flow
One participant randomized to asenapine 2.5 mg BID did not receive study drug but was recorded in clinical database as completing the study. In Participant Flow table, this participant is presented as Not Completed in period "Randomization through Start Treatment" (Not Treated).
Participant milestones
| Measure |
Asenapine 2.5 mg BID
Participants were administered one 2.5 mg asenapine tablet twice daily (BID) for 42 days
|
Asenapine 5 mg BID
Participants were administered one 5 mg asenapine tablet BID for 42 days
|
Olanzapine 15 mg QD
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) once daily (QD) for 42 days, except during Week 1 olanzapine 10 mg QD was administered
|
Placebo BID
Participants were administered placebo tablets BID for 42 days
|
|---|---|---|---|---|
|
Randomization Through Start Treatment
STARTED
|
98
|
113
|
46
|
103
|
|
Randomization Through Start Treatment
COMPLETED
|
97
|
113
|
46
|
101
|
|
Randomization Through Start Treatment
NOT COMPLETED
|
1
|
0
|
0
|
2
|
|
Treatment Through Study Completion
STARTED
|
97
|
113
|
46
|
101
|
|
Treatment Through Study Completion
COMPLETED
|
86
|
102
|
41
|
91
|
|
Treatment Through Study Completion
NOT COMPLETED
|
11
|
11
|
5
|
10
|
Reasons for withdrawal
| Measure |
Asenapine 2.5 mg BID
Participants were administered one 2.5 mg asenapine tablet twice daily (BID) for 42 days
|
Asenapine 5 mg BID
Participants were administered one 5 mg asenapine tablet BID for 42 days
|
Olanzapine 15 mg QD
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) once daily (QD) for 42 days, except during Week 1 olanzapine 10 mg QD was administered
|
Placebo BID
Participants were administered placebo tablets BID for 42 days
|
|---|---|---|---|---|
|
Randomization Through Start Treatment
Not Treated: Administrative Reason
|
0
|
0
|
0
|
1
|
|
Randomization Through Start Treatment
Not Treated: Adverse Event
|
0
|
0
|
0
|
1
|
|
Randomization Through Start Treatment
Not Treated: Completed study in database
|
1
|
0
|
0
|
0
|
|
Treatment Through Study Completion
Adverse Event
|
1
|
1
|
0
|
1
|
|
Treatment Through Study Completion
Lost to Follow-up
|
4
|
2
|
2
|
2
|
|
Treatment Through Study Completion
Withdrawal by Subject
|
5
|
8
|
3
|
6
|
|
Treatment Through Study Completion
Protocol Violation
|
1
|
0
|
0
|
1
|
Baseline Characteristics
A Study of the Efficacy and Safety of Asenapine in Participants With an Acute Exacerbation of Schizophrenia (P05688)
Baseline characteristics by cohort
| Measure |
Asenapine 2.5 mg BID
n=97 Participants
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
|
Asenapine 5 mg BID
n=113 Participants
Participants were administered one 5 mg asenapine tablet BID for 42 days
|
Olanzapine 15 mg QD
n=46 Participants
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
|
Placebo BID
n=101 Participants
Participants were administered placebo tablets BID for 42 days
|
Total
n=357 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
41.5 years
STANDARD_DEVIATION 10.79 • n=5 Participants
|
39.1 years
STANDARD_DEVIATION 10.68 • n=7 Participants
|
40.8 years
STANDARD_DEVIATION 11.15 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 12.05 • n=4 Participants
|
40.6 years
STANDARD_DEVIATION 11.18 • n=21 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
148 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
209 Participants
n=21 Participants
|
|
Positive and Negative Syndrome Scale (PANSS) total score
|
93.3 score on a scale
STANDARD_DEVIATION 11.10 • n=5 Participants
|
95.8 score on a scale
STANDARD_DEVIATION 13.77 • n=7 Participants
|
92.7 score on a scale
STANDARD_DEVIATION 10.47 • n=5 Participants
|
93.4 score on a scale
STANDARD_DEVIATION 11.16 • n=4 Participants
|
94.1 score on a scale
STANDARD_DEVIATION 11.97 • n=21 Participants
|
|
Clinical Global Impression Scale-Severity (CGI-S) score
|
4.8 score on a scale
STANDARD_DEVIATION 0.64 • n=5 Participants
|
4.9 score on a scale
STANDARD_DEVIATION 0.64 • n=7 Participants
|
4.8 score on a scale
STANDARD_DEVIATION 0.61 • n=5 Participants
|
4.8 score on a scale
STANDARD_DEVIATION 0.61 • n=4 Participants
|
4.8 score on a scale
STANDARD_DEVIATION 0.63 • n=21 Participants
|
|
Body Weight
|
81.6 kg
STANDARD_DEVIATION 17.73 • n=5 Participants
|
78.6 kg
STANDARD_DEVIATION 17.88 • n=7 Participants
|
80.7 kg
STANDARD_DEVIATION 17.79 • n=5 Participants
|
77.1 kg
STANDARD_DEVIATION 17.56 • n=4 Participants
|
79.3 kg
STANDARD_DEVIATION 17.75 • n=21 Participants
|
|
PANSS negative subscale score
|
23.5 score on a scale
STANDARD_DEVIATION 4.47 • n=5 Participants
|
24.1 score on a scale
STANDARD_DEVIATION 4.50 • n=7 Participants
|
23.4 score on a scale
STANDARD_DEVIATION 3.96 • n=5 Participants
|
23.9 score on a scale
STANDARD_DEVIATION 4.22 • n=4 Participants
|
23.8 score on a scale
STANDARD_DEVIATION 4.34 • n=21 Participants
|
|
PANSS positive subscale score
|
24.4 score on a scale
STANDARD_DEVIATION 4.05 • n=5 Participants
|
25.5 score on a scale
STANDARD_DEVIATION 4.76 • n=7 Participants
|
24.6 score on a scale
STANDARD_DEVIATION 3.46 • n=5 Participants
|
24.6 score on a scale
STANDARD_DEVIATION 3.88 • n=4 Participants
|
24.8 score on a scale
STANDARD_DEVIATION 4.19 • n=21 Participants
|
|
PANSS general psychopathology subscale score
|
45.5 score on a scale
STANDARD_DEVIATION 6.05 • n=5 Participants
|
46.3 score on a scale
STANDARD_DEVIATION 6.87 • n=7 Participants
|
44.7 score on a scale
STANDARD_DEVIATION 6.20 • n=5 Participants
|
44.9 score on a scale
STANDARD_DEVIATION 6.05 • n=4 Participants
|
45.5 score on a scale
STANDARD_DEVIATION 6.34 • n=21 Participants
|
|
PANSS Marder factor positive symptom score
|
29.3 score on a scale
STANDARD_DEVIATION 5.02 • n=5 Participants
|
30.0 score on a scale
STANDARD_DEVIATION 5.05 • n=7 Participants
|
29.0 score on a scale
STANDARD_DEVIATION 4.69 • n=5 Participants
|
29.4 score on a scale
STANDARD_DEVIATION 4.36 • n=4 Participants
|
29.5 score on a scale
STANDARD_DEVIATION 4.80 • n=21 Participants
|
|
PANSS Marder factor negative symptom score
|
22.6 score on a scale
STANDARD_DEVIATION 4.30 • n=5 Participants
|
23.0 score on a scale
STANDARD_DEVIATION 4.66 • n=7 Participants
|
23.0 score on a scale
STANDARD_DEVIATION 4.44 • n=5 Participants
|
22.8 score on a scale
STANDARD_DEVIATION 4.76 • n=4 Participants
|
22.8 score on a scale
STANDARD_DEVIATION 4.55 • n=21 Participants
|
|
PANSS Marder factor disorganized thought symptom score
|
21.5 score on a scale
STANDARD_DEVIATION 4.32 • n=5 Participants
|
22.6 score on a scale
STANDARD_DEVIATION 4.93 • n=7 Participants
|
21.2 score on a scale
STANDARD_DEVIATION 4.29 • n=5 Participants
|
21.6 score on a scale
STANDARD_DEVIATION 4.42 • n=4 Participants
|
21.8 score on a scale
STANDARD_DEVIATION 4.56 • n=21 Participants
|
|
PANSS Marder factor hostility/excitement symptom score
|
9.0 score on a scale
STANDARD_DEVIATION 2.99 • n=5 Participants
|
9.4 score on a scale
STANDARD_DEVIATION 3.49 • n=7 Participants
|
8.7 score on a scale
STANDARD_DEVIATION 3.11 • n=5 Participants
|
8.8 score on a scale
STANDARD_DEVIATION 3.22 • n=4 Participants
|
9.0 score on a scale
STANDARD_DEVIATION 3.23 • n=21 Participants
|
|
PANSS Marder factor anxiety/depression symptom score
|
11.0 score on a scale
STANDARD_DEVIATION 2.97 • n=5 Participants
|
10.9 score on a scale
STANDARD_DEVIATION 3.13 • n=7 Participants
|
10.9 score on a scale
STANDARD_DEVIATION 3.62 • n=5 Participants
|
10.7 score on a scale
STANDARD_DEVIATION 2.96 • n=4 Participants
|
10.9 score on a scale
STANDARD_DEVIATION 3.09 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 42Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 42; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Asenapine 2.5 mg BID
n=96 Participants
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
|
Asenapine 5 mg BID
n=111 Participants
Participants were administered one 5 mg asenapine tablet BID for 42 days
|
Olanzapine 15 mg QD
n=45 Participants
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
|
Placebo BID
n=99 Participants
Participants were administered placebo tablets BID for 42 days
|
|---|---|---|---|---|
|
Change From Baseline in PANSS Total Score at Day 42
|
-17.4 score on a scale
Standard Error 1.80
|
-21.7 score on a scale
Standard Error 1.60
|
-21.6 score on a scale
Standard Error 2.32
|
-16.2 score on a scale
Standard Error 1.71
|
SECONDARY outcome
Timeframe: Baseline and Day 42Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
Change from baseline in CGI-S score at Day 42 is a Key Secondary Outcome Measure. CGI-S is a 7-point scale for assessing the global severity of the participant's illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 42; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Asenapine 2.5 mg BID
n=96 Participants
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
|
Asenapine 5 mg BID
n=111 Participants
Participants were administered one 5 mg asenapine tablet BID for 42 days
|
Olanzapine 15 mg QD
n=45 Participants
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
|
Placebo BID
n=99 Participants
Participants were administered placebo tablets BID for 42 days
|
|---|---|---|---|---|
|
Change From Baseline in CGI-S Score at Day 42
|
-0.9 score on a scale
Standard Error 0.11
|
-1.2 score on a scale
Standard Error 0.10
|
-1.1 score on a scale
Standard Error 0.14
|
-1.0 score on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline and Day 42Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
Rate of PANSS responders at Day 42 is a Key Secondary Outcome Measure. A PANSS responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS total score at a post-baseline assessment. The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. Missing data were imputed by Last Observation Carried Forward (LOCF).
Outcome measures
| Measure |
Asenapine 2.5 mg BID
n=96 Participants
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
|
Asenapine 5 mg BID
n=111 Participants
Participants were administered one 5 mg asenapine tablet BID for 42 days
|
Olanzapine 15 mg QD
n=45 Participants
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
|
Placebo BID
n=99 Participants
Participants were administered placebo tablets BID for 42 days
|
|---|---|---|---|---|
|
Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42
|
14.6 percentage of participants
0.11
|
25.2 percentage of participants
0.10
|
26.7 percentage of participants
0.14
|
19.2 percentage of participants
0.11
|
SECONDARY outcome
Timeframe: Baseline and Day 42Population: All randomized participants who received ≥1 dose of study drug
Change from baseline in body weight at Day 42 is the Key Safety Outcome Measure.
Outcome measures
| Measure |
Asenapine 2.5 mg BID
n=97 Participants
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
|
Asenapine 5 mg BID
n=113 Participants
Participants were administered one 5 mg asenapine tablet BID for 42 days
|
Olanzapine 15 mg QD
n=46 Participants
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
|
Placebo BID
n=101 Participants
Participants were administered placebo tablets BID for 42 days
|
|---|---|---|---|---|
|
Change From Baseline in Body Weight at Day 42
|
1.3 kg
Standard Error 0.38
|
1.3 kg
Standard Error 0.33
|
2.4 kg
Standard Error 0.47
|
0.3 kg
Standard Error 0.35
|
SECONDARY outcome
Timeframe: Baseline and Days 4, 7, 14, 21, 28 and 35Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Asenapine 2.5 mg BID
n=96 Participants
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
|
Asenapine 5 mg BID
n=111 Participants
Participants were administered one 5 mg asenapine tablet BID for 42 days
|
Olanzapine 15 mg QD
n=45 Participants
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
|
Placebo BID
n=99 Participants
Participants were administered placebo tablets BID for 42 days
|
|---|---|---|---|---|
|
Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35
Day 4
|
-4.0 score on a scale
Standard Error 0.80
|
-4.9 score on a scale
Standard Error 0.76
|
-5.5 score on a scale
Standard Error 1.15
|
-4.8 score on a scale
Standard Error 0.81
|
|
Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35
Day 7
|
-7.2 score on a scale
Standard Error 1.17
|
-9.1 score on a scale
Standard Error 1.09
|
-9.3 score on a scale
Standard Error 1.67
|
-7.1 score on a scale
Standard Error 1.16
|
|
Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35
Day 14
|
-9.9 score on a scale
Standard Error 1.31
|
-12.5 score on a scale
Standard Error 1.19
|
-12.4 score on a scale
Standard Error 1.80
|
-10.7 score on a scale
Standard Error 1.28
|
|
Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35
Day 21
|
-12.0 score on a scale
Standard Error 1.55
|
-14.8 score on a scale
Standard Error 1.40
|
-15.2 score on a scale
Standard Error 2.09
|
-13.2 score on a scale
Standard Error 1.50
|
|
Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35
Day 28
|
-12.3 score on a scale
Standard Error 1.69
|
-17.1 score on a scale
Standard Error 1.49
|
-17.3 score on a scale
Standard Error 2.21
|
-15.5 score on a scale
Standard Error 1.61
|
|
Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35
Day 35
|
-17.0 score on a scale
Standard Error 1.66
|
-19.0 score on a scale
Standard Error 1.48
|
-20.3 score on a scale
Standard Error 2.19
|
-15.4 score on a scale
Standard Error 1.58
|
SECONDARY outcome
Timeframe: Days 4, 7, 14, 21, 28 and 35Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
A PANSS responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS total score at a post-baseline assessment. The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF.
Outcome measures
| Measure |
Asenapine 2.5 mg BID
n=96 Participants
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
|
Asenapine 5 mg BID
n=111 Participants
Participants were administered one 5 mg asenapine tablet BID for 42 days
|
Olanzapine 15 mg QD
n=45 Participants
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
|
Placebo BID
n=99 Participants
Participants were administered placebo tablets BID for 42 days
|
|---|---|---|---|---|
|
Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35
Day 4 (n = 95,108,44,97)
|
0.0 percentage of participants
0.27
|
0.0 percentage of participants
0.25
|
0.0 percentage of participants
0.38
|
2.1 percentage of participants
0.27
|
|
Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35
Day 7 (n = 96,111,45,99)
|
2.1 percentage of participants
0.30
|
5.4 percentage of participants
0.28
|
0.0 percentage of participants
0.43
|
5.1 percentage of participants
0.30
|
|
Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35
Day 14 (n = 96,111,45,99)
|
5.2 percentage of participants
0.31
|
5.4 percentage of participants
0.28
|
4.4 percentage of participants
0.42
|
7.1 percentage of participants
0.30
|
|
Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35
Day 21 (n = 96,111,45,99)
|
8.3 percentage of participants
0.32
|
14.4 percentage of participants
0.29
|
11.1 percentage of participants
0.42
|
13.1 percentage of participants
0.31
|
|
Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35
Day 28 (n = 96,111,45,99)
|
10.4 percentage of participants
0.36
|
16.2 percentage of participants
0.32
|
15.6 percentage of participants
0.47
|
14.1 percentage of participants
0.35
|
|
Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35
Day 35 (n = 96,111,45,99)
|
15.6 percentage of participants
0.34
|
21.6 percentage of participants
0.30
|
15.6 percentage of participants
0.44
|
17.2 percentage of participants
0.32
|
SECONDARY outcome
Timeframe: Baseline and Days 4, 7, 14, 21, 28 and 35Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
CGI-S is a 7-point scale for assessing the global severity of the participant's illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Asenapine 2.5 mg BID
n=96 Participants
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
|
Asenapine 5 mg BID
n=111 Participants
Participants were administered one 5 mg asenapine tablet BID for 42 days
|
Olanzapine 15 mg QD
n=45 Participants
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
|
Placebo BID
n=99 Participants
Participants were administered placebo tablets BID for 42 days
|
|---|---|---|---|---|
|
Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35
Day 4
|
-0.1 score on a scale
Standard Error 0.05
|
-0.2 score on a scale
Standard Error 0.05
|
-0.2 score on a scale
Standard Error 0.07
|
-0.2 score on a scale
Standard Error 0.05
|
|
Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35
Day 7
|
-0.3 score on a scale
Standard Error 0.07
|
-0.3 score on a scale
Standard Error 0.06
|
-0.3 score on a scale
Standard Error 0.10
|
-0.3 score on a scale
Standard Error 0.07
|
|
Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35
Day 14
|
-0.6 score on a scale
Standard Error 0.08
|
-0.6 score on a scale
Standard Error 0.07
|
-0.6 score on a scale
Standard Error 0.11
|
-0.5 score on a scale
Standard Error 0.08
|
|
Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35
Day 21
|
-0.6 score on a scale
Standard Error 0.10
|
-0.8 score on a scale
Standard Error 0.09
|
-0.8 score on a scale
Standard Error 0.13
|
-0.7 score on a scale
Standard Error 0.09
|
|
Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35
Day 28
|
-0.7 score on a scale
Standard Error 0.11
|
-0.9 score on a scale
Standard Error 0.09
|
-0.8 score on a scale
Standard Error 0.14
|
-0.8 score on a scale
Standard Error 0.10
|
|
Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35
Day 35
|
-0.9 score on a scale
Standard Error 0.11
|
-1.1 score on a scale
Standard Error 0.10
|
-1.0 score on a scale
Standard Error 0.14
|
-0.8 score on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Days 4, 7, 14, 21, 28, 35 and 42Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
A CGI-I responder was defined as a participant who had a CGI-I score of 1 (very much improved) or 2 (much improved) at a post-baseline assessment. CGI-I is a 7-point scale for assessing the global improvement of the participant's illness relative to baseline, with ratings from 1=very much improved to 7=very much worse. Missing data were imputed by LOCF.
Outcome measures
| Measure |
Asenapine 2.5 mg BID
n=96 Participants
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
|
Asenapine 5 mg BID
n=111 Participants
Participants were administered one 5 mg asenapine tablet BID for 42 days
|
Olanzapine 15 mg QD
n=45 Participants
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
|
Placebo BID
n=99 Participants
Participants were administered placebo tablets BID for 42 days
|
|---|---|---|---|---|
|
Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42
Day 4 (n = 95,108,44,98)
|
34.7 percentage of participants
0.27
|
33.3 percentage of participants
0.25
|
43.2 percentage of participants
0.38
|
37.8 percentage of participants
0.27
|
|
Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42
Day 7 (n = 96,111,45,99)
|
51.0 percentage of participants
0.30
|
46.8 percentage of participants
0.28
|
60.0 percentage of participants
0.43
|
45.5 percentage of participants
0.30
|
|
Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42
Day 14 (n = 96,111,45,99)
|
51.0 percentage of participants
0.31
|
60.4 percentage of participants
0.28
|
71.1 percentage of participants
0.42
|
54.5 percentage of participants
0.30
|
|
Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42
Day 21 (n = 96,111,45,99)
|
54.2 percentage of participants
0.32
|
63.1 percentage of participants
0.29
|
75.6 percentage of participants
0.42
|
58.6 percentage of participants
0.31
|
|
Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42
Day 28 (n = 96,111,45,99)
|
58.3 percentage of participants
0.36
|
62.2 percentage of participants
0.32
|
73.3 percentage of participants
0.47
|
60.6 percentage of participants
0.35
|
|
Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42
Day 35 (n = 96,111,45,99)
|
60.4 percentage of participants
0.34
|
64.0 percentage of participants
0.30
|
82.2 percentage of participants
0.44
|
64.6 percentage of participants
0.32
|
|
Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42
Day 42 (n = 96,111,45,99)
|
59.4 percentage of participants
0.40
|
66.7 percentage of participants
0.35
|
84.4 percentage of participants
0.50
|
62.6 percentage of participants
0.38
|
SECONDARY outcome
Timeframe: Baseline and Days 4, 7, 14, 21, 28, 35 and 42Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
This measure reports results for the 7 items of the negative subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS negative subscale score for each participant was sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Asenapine 2.5 mg BID
n=96 Participants
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
|
Asenapine 5 mg BID
n=111 Participants
Participants were administered one 5 mg asenapine tablet BID for 42 days
|
Olanzapine 15 mg QD
n=45 Participants
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
|
Placebo BID
n=99 Participants
Participants were administered placebo tablets BID for 42 days
|
|---|---|---|---|---|
|
Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 4
|
-0.7 score on a scale
Standard Error 0.29
|
-0.5 score on a scale
Standard Error 0.27
|
-0.9 score on a scale
Standard Error 0.42
|
-0.8 score on a scale
Standard Error 0.29
|
|
Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 7
|
-1.2 score on a scale
Standard Error 0.33
|
-1.3 score on a scale
Standard Error 0.31
|
-1.5 score on a scale
Standard Error 0.47
|
-1.1 score on a scale
Standard Error 0.33
|
|
Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 14
|
-1.6 score on a scale
Standard Error 0.37
|
-2.3 score on a scale
Standard Error 0.34
|
-1.7 score on a scale
Standard Error 0.51
|
-1.8 score on a scale
Standard Error 0.37
|
|
Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 21
|
-2.3 score on a scale
Standard Error 0.41
|
-2.5 score on a scale
Standard Error 0.37
|
-2.0 score on a scale
Standard Error 0.56
|
-2.3 score on a scale
Standard Error 0.40
|
|
Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 28
|
-2.5 score on a scale
Standard Error 0.45
|
-3.1 score on a scale
Standard Error 0.40
|
-2.6 score on a scale
Standard Error 0.59
|
-3.0 score on a scale
Standard Error 0.43
|
|
Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 35
|
-3.3 score on a scale
Standard Error 0.48
|
-3.4 score on a scale
Standard Error 0.43
|
-3.4 score on a scale
Standard Error 0.63
|
-2.6 score on a scale
Standard Error 0.46
|
|
Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 42
|
-3.3 score on a scale
Standard Error 0.54
|
-4.3 score on a scale
Standard Error 0.48
|
-3.8 score on a scale
Standard Error 0.68
|
-3.2 score on a scale
Standard Error 0.51
|
SECONDARY outcome
Timeframe: Baseline and Days 4, 7, 14, 21, 28, 35 and 42Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
This measure reports results for the 7 items of the positive subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS positive subscale score for each participant was sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Asenapine 2.5 mg BID
n=96 Participants
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
|
Asenapine 5 mg BID
n=111 Participants
Participants were administered one 5 mg asenapine tablet BID for 42 days
|
Olanzapine 15 mg QD
n=45 Participants
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
|
Placebo BID
n=99 Participants
Participants were administered placebo tablets BID for 42 days
|
|---|---|---|---|---|
|
Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 4
|
-1.2 score on a scale
Standard Error 0.29
|
-1.6 score on a scale
Standard Error 0.28
|
-2.3 score on a scale
Standard Error 0.42
|
-1.7 score on a scale
Standard Error 0.30
|
|
Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 7
|
-2.3 score on a scale
Standard Error 0.39
|
-2.8 score on a scale
Standard Error 0.36
|
-3.6 score on a scale
Standard Error 0.55
|
-2.6 score on a scale
Standard Error 0.38
|
|
Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 14
|
-3.4 score on a scale
Standard Error 0.45
|
-3.9 score on a scale
Standard Error 0.40
|
-4.4 score on a scale
Standard Error 0.61
|
-3.7 score on a scale
Standard Error 0.43
|
|
Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 21
|
-4.0 score on a scale
Standard Error 0.52
|
-5.0 score on a scale
Standard Error 0.47
|
-5.7 score on a scale
Standard Error 0.70
|
-4.5 score on a scale
Standard Error 0.51
|
|
Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 28
|
-4.1 score on a scale
Standard Error 0.59
|
-5.7 score on a scale
Standard Error 0.52
|
-6.2 score on a scale
Standard Error 0.77
|
-5.0 score on a scale
Standard Error 0.56
|
|
Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 35
|
-5.2 score on a scale
Standard Error 0.60
|
-6.3 score on a scale
Standard Error 0.53
|
-6.8 score on a scale
Standard Error 0.78
|
-5.5 score on a scale
Standard Error 0.57
|
|
Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 42
|
-5.6 score on a scale
Standard Error 0.65
|
-7.2 score on a scale
Standard Error 0.57
|
-7.5 score on a scale
Standard Error 0.83
|
-5.4 score on a scale
Standard Error 0.61
|
SECONDARY outcome
Timeframe: Baseline and Days 4, 7, 14, 21, 28, 35 and 42Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
This measure reports results for the 16 items of the general psychopathology subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS general psychopathology subscale score for each participant was calculated as the sum of the rating assigned to each of the 16 subscale items, and ranged from 16 to 112 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Asenapine 2.5 mg BID
n=96 Participants
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
|
Asenapine 5 mg BID
n=111 Participants
Participants were administered one 5 mg asenapine tablet BID for 42 days
|
Olanzapine 15 mg QD
n=45 Participants
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
|
Placebo BID
n=99 Participants
Participants were administered placebo tablets BID for 42 days
|
|---|---|---|---|---|
|
Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 4
|
-2.2 score on a scale
Standard Error 0.49
|
-2.7 score on a scale
Standard Error 0.46
|
-2.5 score on a scale
Standard Error 0.70
|
-2.4 score on a scale
Standard Error 0.49
|
|
Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 7
|
-3.8 score on a scale
Standard Error 0.69
|
-4.9 score on a scale
Standard Error 0.64
|
-4.4 score on a scale
Standard Error 0.98
|
-3.6 score on a scale
Standard Error 0.68
|
|
Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 14
|
-5.1 score on a scale
Standard Error 0.73
|
-6.2 score on a scale
Standard Error 0.66
|
-6.4 score on a scale
Standard Error 1.00
|
-5.4 score on a scale
Standard Error 0.71
|
|
Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 21
|
-5.9 score on a scale
Standard Error 0.84
|
-7.4 score on a scale
Standard Error 0.76
|
-7.7 score on a scale
Standard Error 1.13
|
-6.7 score on a scale
Standard Error 0.81
|
|
Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 28
|
-5.9 score on a scale
Standard Error 0.93
|
-8.2 score on a scale
Standard Error 0.82
|
-8.6 score on a scale
Standard Error 1.21
|
-7.7 score on a scale
Standard Error 0.88
|
|
Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 35
|
-8.8 score on a scale
Standard Error 0.88
|
-9.2 score on a scale
Standard Error 0.79
|
-10.2 score on a scale
Standard Error 1.16
|
-7.6 score on a scale
Standard Error 0.84
|
|
Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 42
|
-8.9 score on a scale
Standard Error 0.97
|
-10.1 score on a scale
Standard Error 0.86
|
-10.4 score on a scale
Standard Error 1.23
|
-8.0 score on a scale
Standard Error 0.92
|
SECONDARY outcome
Timeframe: Baseline and Days 4, 7, 14, 21, 28, 35 and 42Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
This measure reports results for the 8 items of the Marder positive symptom factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor positive symptom score for each participant was sum of rating assigned to each of the 8 applicable Marder factor items, and ranged from 8 to 56 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Asenapine 2.5 mg BID
n=96 Participants
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
|
Asenapine 5 mg BID
n=111 Participants
Participants were administered one 5 mg asenapine tablet BID for 42 days
|
Olanzapine 15 mg QD
n=45 Participants
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
|
Placebo BID
n=99 Participants
Participants were administered placebo tablets BID for 42 days
|
|---|---|---|---|---|
|
Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 4
|
-1.3 score on a scale
Standard Error 0.29
|
-1.8 score on a scale
Standard Error 0.27
|
-2.0 score on a scale
Standard Error 0.41
|
-2.0 score on a scale
Standard Error 0.29
|
|
Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 7
|
-2.5 score on a scale
Standard Error 0.41
|
-2.9 score on a scale
Standard Error 0.38
|
-3.2 score on a scale
Standard Error 0.58
|
-2.8 score on a scale
Standard Error 0.40
|
|
Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 14
|
-3.9 score on a scale
Standard Error 0.49
|
-4.0 score on a scale
Standard Error 0.44
|
-4.4 score on a scale
Standard Error 0.67
|
-4.1 score on a scale
Standard Error 0.47
|
|
Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 21
|
-4.5 score on a scale
Standard Error 0.55
|
-5.4 score on a scale
Standard Error 0.50
|
-5.5 score on a scale
Standard Error 0.74
|
-5.1 score on a scale
Standard Error 0.54
|
|
Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 28
|
-4.8 score on a scale
Standard Error 0.60
|
-6.3 score on a scale
Standard Error 0.53
|
-6.6 score on a scale
Standard Error 0.78
|
-5.6 score on a scale
Standard Error 0.57
|
|
Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 35
|
-6.1 score on a scale
Standard Error 0.64
|
-6.7 score on a scale
Standard Error 0.57
|
-6.9 score on a scale
Standard Error 0.84
|
-6.1 score on a scale
Standard Error 0.61
|
|
Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 42
|
-6.8 score on a scale
Standard Error 0.67
|
-7.6 score on a scale
Standard Error 0.59
|
-7.8 score on a scale
Standard Error 0.86
|
-6.2 score on a scale
Standard Error 0.63
|
SECONDARY outcome
Timeframe: Baseline and Days 4, 7, 14, 21, 28, 35 and 42Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
This measure reports results for the 7 items of the Marder negative symptoms factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor negative symptom score for each participant was sum of the rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Asenapine 2.5 mg BID
n=96 Participants
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
|
Asenapine 5 mg BID
n=111 Participants
Participants were administered one 5 mg asenapine tablet BID for 42 days
|
Olanzapine 15 mg QD
n=45 Participants
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
|
Placebo BID
n=99 Participants
Participants were administered placebo tablets BID for 42 days
|
|---|---|---|---|---|
|
Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 4
|
-1.2 score on a scale
Standard Error 0.30
|
-0.8 score on a scale
Standard Error 0.28
|
-0.8 score on a scale
Standard Error 0.43
|
-0.7 score on a scale
Standard Error 0.30
|
|
Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 7
|
-1.7 score on a scale
Standard Error 0.37
|
-1.9 score on a scale
Standard Error 0.34
|
-1.8 score on a scale
Standard Error 0.53
|
-1.3 score on a scale
Standard Error 0.37
|
|
Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 14
|
-2.0 score on a scale
Standard Error 0.41
|
-2.8 score on a scale
Standard Error 0.37
|
-2.2 score on a scale
Standard Error 0.56
|
-2.0 score on a scale
Standard Error 0.40
|
|
Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 21
|
-2.6 score on a scale
Standard Error 0.44
|
-3.2 score on a scale
Standard Error 0.40
|
-2.6 score on a scale
Standard Error 0.60
|
-2.5 score on a scale
Standard Error 0.43
|
|
Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 28
|
-2.9 score on a scale
Standard Error 0.51
|
-3.8 score on a scale
Standard Error 0.45
|
-3.2 score on a scale
Standard Error 0.67
|
-3.5 score on a scale
Standard Error 0.49
|
|
Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 35
|
-3.5 score on a scale
Standard Error 0.52
|
-3.9 score on a scale
Standard Error 0.46
|
-4.1 score on a scale
Standard Error 0.68
|
-3.0 score on a scale
Standard Error 0.49
|
|
Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 42
|
-3.4 score on a scale
Standard Error 0.53
|
-4.7 score on a scale
Standard Error 0.47
|
-4.3 score on a scale
Standard Error 0.67
|
-4.0 score on a scale
Standard Error 0.51
|
SECONDARY outcome
Timeframe: Baseline and Days 4, 7, 14, 21, 28, 35 and 42Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
This measure reports results for the 7 items of the Marder disorganized thoughts factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor disorganized thought symptom score for each participant was sum of rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Asenapine 2.5 mg BID
n=96 Participants
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
|
Asenapine 5 mg BID
n=111 Participants
Participants were administered one 5 mg asenapine tablet BID for 42 days
|
Olanzapine 15 mg QD
n=45 Participants
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
|
Placebo BID
n=99 Participants
Participants were administered placebo tablets BID for 42 days
|
|---|---|---|---|---|
|
Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 4
|
-0.3 score on a scale
Standard Error 0.24
|
-0.7 score on a scale
Standard Error 0.22
|
-1.1 score on a scale
Standard Error 0.34
|
-0.7 score on a scale
Standard Error 0.24
|
|
Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 7
|
-1.0 score on a scale
Standard Error 0.32
|
-1.4 score on a scale
Standard Error 0.29
|
-1.6 score on a scale
Standard Error 0.45
|
-0.7 score on a scale
Standard Error 0.31
|
|
Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 14
|
-1.3 score on a scale
Standard Error 0.36
|
-2.0 score on a scale
Standard Error 0.33
|
-2.2 score on a scale
Standard Error 0.49
|
-1.5 score on a scale
Standard Error 0.35
|
|
Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 21
|
-2.3 score on a scale
Standard Error 0.41
|
-2.5 score on a scale
Standard Error 0.37
|
-2.7 score on a scale
Standard Error 0.54
|
-2.1 score on a scale
Standard Error 0.39
|
|
Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 28
|
-2.4 score on a scale
Standard Error 0.42
|
-3.1 score on a scale
Standard Error 0.37
|
-3.1 score on a scale
Standard Error 0.54
|
-2.4 score on a scale
Standard Error 0.40
|
|
Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 35
|
-3.5 score on a scale
Standard Error 0.43
|
-3.5 score on a scale
Standard Error 0.38
|
-4.3 score on a scale
Standard Error 0.56
|
-2.4 score on a scale
Standard Error 0.41
|
|
Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 42
|
-3.8 score on a scale
Standard Error 0.45
|
-4.3 score on a scale
Standard Error 0.40
|
-4.7 score on a scale
Standard Error 0.58
|
-2.7 score on a scale
Standard Error 0.43
|
SECONDARY outcome
Timeframe: Baseline and Days 4, 7, 14, 21, 28, 35 and 42Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
This measure reports results for the 4 items of the Marder hostility/excitement factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor hostility/excitement symptom score for each participant was sum of rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Asenapine 2.5 mg BID
n=96 Participants
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
|
Asenapine 5 mg BID
n=111 Participants
Participants were administered one 5 mg asenapine tablet BID for 42 days
|
Olanzapine 15 mg QD
n=45 Participants
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
|
Placebo BID
n=99 Participants
Participants were administered placebo tablets BID for 42 days
|
|---|---|---|---|---|
|
Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 4
|
-0.4 score on a scale
Standard Error 0.25
|
-0.3 score on a scale
Standard Error 0.23
|
-0.7 score on a scale
Standard Error 0.36
|
-0.5 score on a scale
Standard Error 0.25
|
|
Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 7
|
-0.5 score on a scale
Standard Error 0.28
|
-0.5 score on a scale
Standard Error 0.26
|
-1.0 score on a scale
Standard Error 0.40
|
-0.7 score on a scale
Standard Error 0.28
|
|
Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 14
|
-0.9 score on a scale
Standard Error 0.30
|
-0.8 score on a scale
Standard Error 0.27
|
-1.2 score on a scale
Standard Error 0.41
|
-0.9 score on a scale
Standard Error 0.30
|
|
Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 21
|
-0.8 score on a scale
Standard Error 0.33
|
-0.9 score on a scale
Standard Error 0.30
|
-1.8 score on a scale
Standard Error 0.44
|
-1.0 score on a scale
Standard Error 0.32
|
|
Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 28
|
-0.5 score on a scale
Standard Error 0.41
|
-0.8 score on a scale
Standard Error 0.36
|
-1.6 score on a scale
Standard Error 0.53
|
-1.0 score on a scale
Standard Error 0.39
|
|
Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 35
|
-1.4 score on a scale
Standard Error 0.37
|
-1.5 score on a scale
Standard Error 0.32
|
-2.0 score on a scale
Standard Error 0.47
|
-1.4 score on a scale
Standard Error 0.35
|
|
Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 42
|
-1.1 score on a scale
Standard Error 0.41
|
-1.8 score on a scale
Standard Error 0.36
|
-1.9 score on a scale
Standard Error 0.52
|
-1.1 score on a scale
Standard Error 0.39
|
SECONDARY outcome
Timeframe: Baseline and Days 4, 7, 14, 21, 28, 35 and 42Population: FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score
This measure reports results for the 4 items of the Marder anxiety/depression factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor anxiety/depression symptom score for each participant was sum of rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Asenapine 2.5 mg BID
n=96 Participants
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
|
Asenapine 5 mg BID
n=111 Participants
Participants were administered one 5 mg asenapine tablet BID for 42 days
|
Olanzapine 15 mg QD
n=45 Participants
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
|
Placebo BID
n=99 Participants
Participants were administered placebo tablets BID for 42 days
|
|---|---|---|---|---|
|
Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 4
|
-0.9 score on a scale
Standard Error 0.27
|
-1.2 score on a scale
Standard Error 0.25
|
-1.0 score on a scale
Standard Error 0.38
|
-0.9 score on a scale
Standard Error 0.27
|
|
Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 7
|
-1.5 score on a scale
Standard Error 0.30
|
-2.2 score on a scale
Standard Error 0.28
|
-1.8 score on a scale
Standard Error 0.43
|
-1.7 score on a scale
Standard Error 0.30
|
|
Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 14
|
-1.9 score on a scale
Standard Error 0.31
|
-2.9 score on a scale
Standard Error 0.28
|
-2.5 score on a scale
Standard Error 0.42
|
-2.5 score on a scale
Standard Error 0.30
|
|
Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 21
|
-2.1 score on a scale
Standard Error 0.32
|
-3.0 score on a scale
Standard Error 0.29
|
-2.7 score on a scale
Standard Error 0.42
|
-3.1 score on a scale
Standard Error 0.31
|
|
Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 28
|
-1.9 score on a scale
Standard Error 0.36
|
-3.2 score on a scale
Standard Error 0.32
|
-2.8 score on a scale
Standard Error 0.47
|
-3.4 score on a scale
Standard Error 0.35
|
|
Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 35
|
-3.0 score on a scale
Standard Error 0.34
|
-3.6 score on a scale
Standard Error 0.30
|
-3.2 score on a scale
Standard Error 0.44
|
-3.2 score on a scale
Standard Error 0.32
|
|
Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42
Day 42
|
-2.9 score on a scale
Standard Error 0.40
|
-3.4 score on a scale
Standard Error 0.35
|
-3.1 score on a scale
Standard Error 0.50
|
-3.0 score on a scale
Standard Error 0.38
|
Adverse Events
Asenapine 2.5 mg BID
Serious events: 5 serious events
Other events: 27 other events
Deaths: 0 deaths
Asenapine 5 mg BID
Serious events: 5 serious events
Other events: 47 other events
Deaths: 0 deaths
Olanzapine 15 mg QD
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo BID
Serious events: 8 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Asenapine 2.5 mg BID
n=97 participants at risk
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
|
Asenapine 5 mg BID
n=113 participants at risk
Participants were administered one 5 mg asenapine tablet BID for 42 days
|
Olanzapine 15 mg QD
n=46 participants at risk
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
|
Placebo BID
n=101 participants at risk
Participants were administered placebo tablets BID for 42 days
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/97 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.88%
1/113 • Number of events 1 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/46 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/101 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
|
General disorders
Chest pain
|
0.00%
0/97 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/113 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/46 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.99%
1/101 • Number of events 1 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/97 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/113 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/46 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.99%
1/101 • Number of events 1 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.0%
1/97 • Number of events 1 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/113 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/46 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/101 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/97 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/113 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/46 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.99%
1/101 • Number of events 1 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
|
Nervous system disorders
Syncope
|
0.00%
0/97 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/113 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/46 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.99%
1/101 • Number of events 1 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
|
Psychiatric disorders
Agitation
|
0.00%
0/97 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/113 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/46 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.99%
1/101 • Number of events 1 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/97 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/113 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/46 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.99%
1/101 • Number of events 1 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
|
Psychiatric disorders
Homicidal ideation
|
1.0%
1/97 • Number of events 1 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/113 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/46 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/101 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
|
Psychiatric disorders
Psychotic disorder
|
2.1%
2/97 • Number of events 2 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/113 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
2.2%
1/46 • Number of events 1 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/101 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/97 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
2.7%
3/113 • Number of events 3 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/46 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
2.0%
2/101 • Number of events 2 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
|
Psychiatric disorders
Schizophrenia, paranoid type
|
0.00%
0/97 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.88%
1/113 • Number of events 1 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/46 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/101 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.0%
1/97 • Number of events 1 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/113 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/46 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/101 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
Other adverse events
| Measure |
Asenapine 2.5 mg BID
n=97 participants at risk
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
|
Asenapine 5 mg BID
n=113 participants at risk
Participants were administered one 5 mg asenapine tablet BID for 42 days
|
Olanzapine 15 mg QD
n=46 participants at risk
Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
|
Placebo BID
n=101 participants at risk
Participants were administered placebo tablets BID for 42 days
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/97 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
1.8%
2/113 • Number of events 2 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
6.5%
3/46 • Number of events 3 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
2.0%
2/101 • Number of events 2 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/97 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
1.8%
2/113 • Number of events 2 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
10.9%
5/46 • Number of events 5 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.99%
1/101 • Number of events 1 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
|
Gastrointestinal disorders
Dyspepsia
|
1.0%
1/97 • Number of events 1 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
1.8%
2/113 • Number of events 2 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
6.5%
3/46 • Number of events 3 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
2.0%
2/101 • Number of events 2 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
4.1%
4/97 • Number of events 4 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
6.2%
7/113 • Number of events 7 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/46 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/101 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/97 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
5.3%
6/113 • Number of events 6 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/46 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/101 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
|
Nervous system disorders
Headache
|
10.3%
10/97 • Number of events 12 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
8.8%
10/113 • Number of events 10 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
8.7%
4/46 • Number of events 6 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
2.0%
2/101 • Number of events 2 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
|
Nervous system disorders
Somnolence
|
3.1%
3/97 • Number of events 3 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
6.2%
7/113 • Number of events 7 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
10.9%
5/46 • Number of events 5 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/101 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
|
Psychiatric disorders
Agitation
|
3.1%
3/97 • Number of events 3 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
6.2%
7/113 • Number of events 8 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/46 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
3.0%
3/101 • Number of events 3 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
|
Psychiatric disorders
Anxiety
|
7.2%
7/97 • Number of events 10 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
7.1%
8/113 • Number of events 9 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
8.7%
4/46 • Number of events 5 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
11.9%
12/101 • Number of events 13 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
|
Psychiatric disorders
Insomnia
|
9.3%
9/97 • Number of events 9 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
15.0%
17/113 • Number of events 21 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
8.7%
4/46 • Number of events 4 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
13.9%
14/101 • Number of events 20 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
|
Psychiatric disorders
Schizophrenia
|
6.2%
6/97 • Number of events 6 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
3.5%
4/113 • Number of events 4 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
0.00%
0/46 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
4.0%
4/101 • Number of events 4 • Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee It is planned to first publish/present trial results together with the other sites, unless permission is obtained from Sponsor to publish separate results. Sponsor must be able to review all proposed results communications regarding study 45 days prior to submission for publication/presentation. If there is disagreement concerning appropriateness of the materials, Investigator and Sponsor must meet to make a good faith effort to discuss/resolve disagreement prior to submission for publication.
- Publication restrictions are in place
Restriction type: OTHER