Trial Outcomes & Findings for Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691) (NCT NCT00764478)
NCT ID: NCT00764478
Last Updated: 2024-06-18
Results Overview
Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a mixed model repeated measures (MMRM) model. An improvement in symptoms is represented by change from baseline values that are negative.
COMPLETED
PHASE3
367 participants
Baseline and Day 21
2024-06-18
Participant Flow
Participant milestones
| Measure |
Asenapine 5 mg BID
Participants were administered one 5 mg asenapine tablet, sublingually twice daily (BID) for 21 days
|
Asenapine 10 mg BID
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
122
|
119
|
126
|
|
Overall Study
COMPLETED
|
107
|
97
|
118
|
|
Overall Study
NOT COMPLETED
|
15
|
22
|
8
|
Reasons for withdrawal
| Measure |
Asenapine 5 mg BID
Participants were administered one 5 mg asenapine tablet, sublingually twice daily (BID) for 21 days
|
Asenapine 10 mg BID
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
12
|
1
|
|
Overall Study
Lost to Follow-up
|
7
|
8
|
5
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
Baseline Characteristics
Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691)
Baseline characteristics by cohort
| Measure |
Asenapine 5 mg BID
n=122 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=119 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=126 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
Total
n=367 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.3 Years
STANDARD_DEVIATION 10.82 • n=5 Participants
|
42.5 Years
STANDARD_DEVIATION 11.06 • n=7 Participants
|
44.6 Years
STANDARD_DEVIATION 11.54 • n=5 Participants
|
43.8 Years
STANDARD_DEVIATION 11.16 • n=4 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
201 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
166 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 21Population: Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.
Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a mixed model repeated measures (MMRM) model. An improvement in symptoms is represented by change from baseline values that are negative.
Outcome measures
| Measure |
Asenapine 5 mg BID
n=120 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=113 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=126 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score at Day 21
|
-14.4 Score on a scale
Standard Error 1.02
|
-14.9 Score on a scale
Standard Error 1.04
|
-10.9 Score on a scale
Standard Error 0.99
|
SECONDARY outcome
Timeframe: Baseline and Day 21Population: Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement. One participant from the Placebo BID arm missed a baseline measurement.
The CGI-BP-S is a score that measures the severity of overall bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Outcome measures
| Measure |
Asenapine 5 mg BID
n=120 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=113 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=125 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Change From Baseline in Clinical Global Impression - Bipolar Mania - Severity of Illness (CGI-BP-S) Overall Score at Day 21
|
-1.6 Score on a scale
Standard Error 0.12
|
-1.7 Score on a scale
Standard Error 0.12
|
-1.1 Score on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Day 21Population: Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.
Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. Missing data were imputed by Last Observation Carried Forward (LOCF). Y-MRS responders are defined as having a \>= 50% decrease from baseline in Y-MRS total score.
Outcome measures
| Measure |
Asenapine 5 mg BID
n=120 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=113 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=126 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Percentage of Participants Who Are Y-MRS Responders at Day 21
|
45.0 Percentage of participants
|
46.9 Percentage of participants
|
39.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Day 2, Day 4, Day 7 and Day 14Population: Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.
Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Outcome measures
| Measure |
Asenapine 5 mg BID
n=120 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=113 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=126 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Change From Baseline in Y-MRS Total Score at Day 2, Day 4, Day 7 and Day 14
Day 2
|
-5.6 Score on a scale
Standard Error 0.57
|
-5.8 Score on a scale
Standard Error 0.59
|
-2.9 Score on a scale
Standard Error 0.56
|
|
Change From Baseline in Y-MRS Total Score at Day 2, Day 4, Day 7 and Day 14
Day 4
|
-8.6 Score on a scale
Standard Error 0.67
|
-8.6 Score on a scale
Standard Error 0.68
|
-4.9 Score on a scale
Standard Error 0.64
|
|
Change From Baseline in Y-MRS Total Score at Day 2, Day 4, Day 7 and Day 14
Day 7
|
-10.0 Score on a scale
Standard Error 0.81
|
-10.7 Score on a scale
Standard Error 0.83
|
-6.6 Score on a scale
Standard Error 0.79
|
|
Change From Baseline in Y-MRS Total Score at Day 2, Day 4, Day 7 and Day 14
Day 14
|
-11.1 Score on a scale
Standard Error 0.98
|
-12.5 Score on a scale
Standard Error 1.00
|
-9.4 Score on a scale
Standard Error 0.95
|
SECONDARY outcome
Timeframe: Day 2, Day 4, Day 7, Day 14Population: Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint.
Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF. Y-MRS responders are defined as having a \>= 50% decrease from baseline in Y-MRS total score.
Outcome measures
| Measure |
Asenapine 5 mg BID
n=120 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=113 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=126 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Percentage of Participants Who Are Y-MRS Responders at Day 2, Day 4, Day 7, Day 14
Day 2 (n = 117,111,123)
|
12.0 Percentage of participants
|
14.4 Percentage of participants
|
8.9 Percentage of participants
|
|
Percentage of Participants Who Are Y-MRS Responders at Day 2, Day 4, Day 7, Day 14
Day 4 (n = 120,113,126)
|
21.7 Percentage of participants
|
23.0 Percentage of participants
|
8.7 Percentage of participants
|
|
Percentage of Participants Who Are Y-MRS Responders at Day 2, Day 4, Day 7, Day 14
Day 7 (n = 120,113,126)
|
31.7 Percentage of participants
|
28.3 Percentage of participants
|
19.8 Percentage of participants
|
|
Percentage of Participants Who Are Y-MRS Responders at Day 2, Day 4, Day 7, Day 14
Day 14 (n = 120,113,126)
|
36.7 Percentage of participants
|
40.7 Percentage of participants
|
33.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 21Population: Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement.
Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF. Y-MRS remitters are defined as having a Y-MRS total score of 12 or lower.
Outcome measures
| Measure |
Asenapine 5 mg BID
n=120 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=113 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=126 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Percentage of Participants Who Are Y-MRS Remitters at Day 21
|
34.2 Percentage of participants
|
38.1 Percentage of participants
|
30.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 2, Day 4, Day 7, Day 14, Day 21Population: Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.
Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a generalized linear mixed model (GLMM). Y-MRS remitters are defined as having a Y-MRS total score of 12 or lower.
Outcome measures
| Measure |
Asenapine 5 mg BID
n=120 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=113 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=126 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Percentage of Participants Who Are Y-MRS Remitters at Day 2, Day 4, Day 7, Day 14, Day 21
Day 2 (n= 117,111, 123)
|
8.5 Percentage of participants
|
11.7 Percentage of participants
|
5.7 Percentage of participants
|
|
Percentage of Participants Who Are Y-MRS Remitters at Day 2, Day 4, Day 7, Day 14, Day 21
Day 4 (n= 104, 106,118)
|
17.3 Percentage of participants
|
15.1 Percentage of participants
|
10.2 Percentage of participants
|
|
Percentage of Participants Who Are Y-MRS Remitters at Day 2, Day 4, Day 7, Day 14, Day 21
Day 7 (n= 104, 101,110)
|
26.9 Percentage of participants
|
24.8 Percentage of participants
|
17.3 Percentage of participants
|
|
Percentage of Participants Who Are Y-MRS Remitters at Day 2, Day 4, Day 7, Day 14, Day 21
Day 14 (n= 96, 91,102)
|
28.1 Percentage of participants
|
27.5 Percentage of participants
|
24.5 Percentage of participants
|
|
Percentage of Participants Who Are Y-MRS Remitters at Day 2, Day 4, Day 7, Day 14, Day 21
Day 21 (n= 86, 83,93)
|
40.7 Percentage of participants
|
43.4 Percentage of participants
|
34.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Day 7 and Day 21Population: Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint.
The MADRS measures depression and consists of 10 items, each rated on a scale from 0 to 6. The MADRS total score sums the scores from the 10 items, ranging from 0 to 60, with a higher numeric rating implying a greater degree of symptom severity. Missing data were imputed by LOCF. An improvement in symptoms is represented by change from baseline values that are negative.
Outcome measures
| Measure |
Asenapine 5 mg BID
n=115 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=110 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=123 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
Day 7 (n=112,106, 117)
|
-4.3 Score on a scale
Standard Error 0.47
|
-4.2 Score on a scale
Standard Error 0.48
|
-2.3 Score on a scale
Standard Error 0.46
|
|
Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
Day 21 (n =115, 110,123)
|
-4.6 Score on a scale
Standard Error 0.61
|
-5.1 Score on a scale
Standard Error 0.63
|
-2.5 Score on a scale
Standard Error 0.60
|
SECONDARY outcome
Timeframe: Baseline and Day 2, Day 4, Day 7, Day 14Population: Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement. One participant from the Placebo BID arm missed a baseline measurement.
The CGI-BP-S is a score that measures the severity of overall bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Outcome measures
| Measure |
Asenapine 5 mg BID
n=120 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=113 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=125 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Change From Baseline in CGI-BP-S Overall Score at Day 2, Day 4, Day 7, Day 14
Day 2
|
-0.5 Score on a scale
Standard Error 0.05
|
-0.4 Score on a scale
Standard Error 0.06
|
-0.2 Score on a scale
Standard Error 0.05
|
|
Change From Baseline in CGI-BP-S Overall Score at Day 2, Day 4, Day 7, Day 14
Day 4
|
-0.8 Score on a scale
Standard Error 0.07
|
-0.7 Score on a scale
Standard Error 0.07
|
-0.4 Score on a scale
Standard Error 0.07
|
|
Change From Baseline in CGI-BP-S Overall Score at Day 2, Day 4, Day 7, Day 14
Day 7
|
-1.0 Score on a scale
Standard Error 0.09
|
-1.1 Score on a scale
Standard Error 0.09
|
-0.7 Score on a scale
Standard Error 0.09
|
|
Change From Baseline in CGI-BP-S Overall Score at Day 2, Day 4, Day 7, Day 14
Day 14
|
-1.3 Score on a scale
Standard Error 0.10
|
-1.3 Score on a scale
Standard Error 0.11
|
-1.0 Score on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline and Day 2, Day 4, Day 7, Day 14, and Day 21Population: Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint. One participant from the Placebo BID arm missed a baseline measurement.
The CGI-BP-S mania is a score that assesses the severity of the mania component of bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. Missing data were imputed by LOCF. An improvement in symptoms is represented by change from baseline values that are negative.
Outcome measures
| Measure |
Asenapine 5 mg BID
n=120 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=113 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=125 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Change From Baseline in CGI-BP-S Mania Score
Day 2 (n=118,111,122)
|
-0.4 Score on a scale
Standard Error 0.06
|
-0.4 Score on a scale
Standard Error 0.06
|
-0.1 Score on a scale
Standard Error 0.06
|
|
Change From Baseline in CGI-BP-S Mania Score
Day 4 (n=120,113,125)
|
-0.7 Score on a scale
Standard Error 0.07
|
-0.7 Score on a scale
Standard Error 0.08
|
-0.3 Score on a scale
Standard Error 0.07
|
|
Change From Baseline in CGI-BP-S Mania Score
Day 7 (n=120,113,125)
|
-0.9 Score on a scale
Standard Error 0.09
|
-1.0 Score on a scale
Standard Error 0.09
|
-0.7 Score on a scale
Standard Error 0.09
|
|
Change From Baseline in CGI-BP-S Mania Score
Day 14 (n=120,113,125)
|
-1.2 Score on a scale
Standard Error 0.10
|
-1.3 Score on a scale
Standard Error 0.11
|
-1.0 Score on a scale
Standard Error 0.10
|
|
Change From Baseline in CGI-BP-S Mania Score
Day 21 (n=120,113,125)
|
-1.4 Score on a scale
Standard Error 0.11
|
-1.5 Score on a scale
Standard Error 0.12
|
-1.1 Score on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline and Day 2, Day 4, Day 7, Day 14, and Day 21Population: Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint.
The CGI-BP-S depression is a score that assesses the severity of the depression component of bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. Missing data were imputed by LOCF. An improvement in symptoms is represented by change from baseline values that are negative.
Outcome measures
| Measure |
Asenapine 5 mg BID
n=120 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=113 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=125 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Change From Baseline in CGI-BP-S Depression Score
Day 2 (n=118,111,122)
|
-0.2 Score on a scale
Standard Error 0.06
|
-0.2 Score on a scale
Standard Error 0.06
|
-0.2 Score on a scale
Standard Error 0.06
|
|
Change From Baseline in CGI-BP-S Depression Score
Day 4 (n=120,113,125)
|
-0.3 Score on a scale
Standard Error 0.06
|
-0.3 Score on a scale
Standard Error 0.06
|
-0.3 Score on a scale
Standard Error 0.06
|
|
Change From Baseline in CGI-BP-S Depression Score
Day 7 (n=120,113,125)
|
-0.3 Score on a scale
Standard Error 0.07
|
-0.4 Score on a scale
Standard Error 0.07
|
-0.1 Score on a scale
Standard Error 0.07
|
|
Change From Baseline in CGI-BP-S Depression Score
Day 14 (n=120,113,125)
|
-0.4 Score on a scale
Standard Error 0.07
|
-0.5 Score on a scale
Standard Error 0.07
|
-0.2 Score on a scale
Standard Error 0.07
|
|
Change From Baseline in CGI-BP-S Depression Score
Day 21 (n=120,113,125)
|
-0.4 Score on a scale
Standard Error 0.08
|
-0.5 Score on a scale
Standard Error 0.08
|
-0.1 Score on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Day 2, Day 4, Day 7, Day 14, and Day 21Population: Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.
The CGI-BP-I overall is a score on a 7-point scale for assessing the change from preceding phase of overall symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-BP-I overall score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. Missing data were imputed by LOCF. A CGI-BP-I responder had a score of 3 (minimally improved) or lower.
Outcome measures
| Measure |
Asenapine 5 mg BID
n=120 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=113 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=126 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Overall Bipolar Illness Score
Day 14 (n=120,113,126)
|
70.8 Percentage of participants
|
83.2 Percentage of participants
|
65.1 Percentage of participants
|
|
Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Overall Bipolar Illness Score
Day 21 (n=120,113,126)
|
74.2 Percentage of participants
|
82.3 Percentage of participants
|
64.3 Percentage of participants
|
|
Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Overall Bipolar Illness Score
Day 2 (n=118,111,123)
|
50.8 Percentage of participants
|
45.9 Percentage of participants
|
37.4 Percentage of participants
|
|
Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Overall Bipolar Illness Score
Day 4 (n=120,113,126)
|
64.2 Percentage of participants
|
64.6 Percentage of participants
|
55.6 Percentage of participants
|
|
Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Overall Bipolar Illness Score
Day 7 (n=120,113,126)
|
73.3 Percentage of participants
|
78.8 Percentage of participants
|
61.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 2, Day 4, Day 7, Day 14, and Day 21Population: Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.
The CGI-BP-I mania is a score on a 7-point scale for assessing the change from preceding phase of mania symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-BP-I mania score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. Missing data were imputed by LOCF. A CGI-BP-I responder had a score of 3 (minimally improved) or lower.
Outcome measures
| Measure |
Asenapine 5 mg BID
n=120 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=113 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=126 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Mania Score
Day 2 (n=118,111,123)
|
49.2 Percentage of participants
|
45.9 Percentage of participants
|
37.4 Percentage of participants
|
|
Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Mania Score
Day 4 (n=120,113,126)
|
64.2 Percentage of participants
|
66.4 Percentage of participants
|
55.6 Percentage of participants
|
|
Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Mania Score
Day 7 (n=120,113,126)
|
74.2 Percentage of participants
|
80.5 Percentage of participants
|
63.5 Percentage of participants
|
|
Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Mania Score
Day 14 (n=120,113,126)
|
75.8 Percentage of participants
|
82.3 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Mania Score
Day 21 (n=120,113,126)
|
79.2 Percentage of participants
|
84.1 Percentage of participants
|
66.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 2, Day 4, Day 7, Day 14, and Day 21Population: Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.
The CGI-BP-I depression is a score on a 7-point scale for assessing the change from preceding phase of depression symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-BP-I depression score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. Missing data were imputed by LOCF. A CGI-BP-I responder had a score of 3 (minimally improved) or lower.
Outcome measures
| Measure |
Asenapine 5 mg BID
n=117 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=106 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=121 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Depression Score
Day 2 (n=113, 103, 116)
|
21.2 Percentage of participants
|
28.2 Percentage of participants
|
11.2 Percentage of participants
|
|
Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Depression Score
Day 4 (n=116, 106, 119)
|
26.7 Percentage of participants
|
32.1 Percentage of participants
|
19.3 Percentage of participants
|
|
Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Depression Score
Day 7 (n=117, 106, 119)
|
31.6 Percentage of participants
|
35.8 Percentage of participants
|
23.5 Percentage of participants
|
|
Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Depression Score
Day 14 (n=117, 106, 120)
|
31.6 Percentage of participants
|
42.5 Percentage of participants
|
26.7 Percentage of participants
|
|
Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Depression Score
Day 21 (n=117, 106, 121)
|
32.5 Percentage of participants
|
44.3 Percentage of participants
|
28.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Day 7, Day 14, Day 21Population: Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.
PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score sums the scores from all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Outcome measures
| Measure |
Asenapine 5 mg BID
n=115 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=110 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=123 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Change From Baseline in Positive And Negative Syndrome Scale (PANSS) Total Score
Day 7
|
-6.9 Score on a scale
Standard Error 0.77
|
-6.9 Score on a scale
Standard Error 0.79
|
-3.9 Score on a scale
Standard Error 0.76
|
|
Change From Baseline in Positive And Negative Syndrome Scale (PANSS) Total Score
Day 14
|
-7.5 Score on a scale
Standard Error 0.96
|
-8.4 Score on a scale
Standard Error 0.99
|
-5.2 Score on a scale
Standard Error 0.94
|
|
Change From Baseline in Positive And Negative Syndrome Scale (PANSS) Total Score
Day 21
|
-9.3 Score on a scale
Standard Error 1.02
|
-8.8 Score on a scale
Standard Error 1.05
|
-5.5 Score on a scale
Standard Error 1.00
|
SECONDARY outcome
Timeframe: Baseline and Day 7, Day 14, Day 21Population: Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.
PANSS Negative subscale measures symptoms of schizophrenia and consists of responses to 7 items (N1-N7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Negative subscale sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Outcome measures
| Measure |
Asenapine 5 mg BID
n=115 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=110 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=123 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Change From Baseline in PANSS Negative Subscale Score
Day 7
|
-0.5 Score on a scale
Standard Error 0.22
|
-0.8 Score on a scale
Standard Error 0.22
|
-0.5 Score on a scale
Standard Error 0.21
|
|
Change From Baseline in PANSS Negative Subscale Score
Day 14
|
-0.8 Score on a scale
Standard Error 0.23
|
-0.7 Score on a scale
Standard Error 0.24
|
-0.8 Score on a scale
Standard Error 0.23
|
|
Change From Baseline in PANSS Negative Subscale Score
Day 21
|
-0.4 Score on a scale
Standard Error 0.28
|
-0.0 Score on a scale
Standard Error 0.29
|
-0.4 Score on a scale
Standard Error 0.27
|
SECONDARY outcome
Timeframe: Baseline and Day 7, Day 14, Day 21Population: Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.
PANSS Positive subscale measures symptoms of schizophrenia and consists of responses to 7 items (P1-P7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Positive subscale sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Outcome measures
| Measure |
Asenapine 5 mg BID
n=115 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=110 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=123 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Change From Baseline in PANSS Positive Subscale Score
Day 7
|
-2.4 Score on a scale
Standard Error 0.30
|
-2.8 Score on a scale
Standard Error 0.31
|
-1.4 Score on a scale
Standard Error 0.29
|
|
Change From Baseline in PANSS Positive Subscale Score
Day 14
|
-2.3 Score on a scale
Standard Error 0.37
|
-3.2 Score on a scale
Standard Error 0.38
|
-2.1 Score on a scale
Standard Error 0.36
|
|
Change From Baseline in PANSS Positive Subscale Score
Day 21
|
-3.5 Score on a scale
Standard Error 0.37
|
-3.9 Score on a scale
Standard Error 0.38
|
-2.4 Score on a scale
Standard Error 0.36
|
SECONDARY outcome
Timeframe: Baseline and Day 7, Day 14, Day 21Population: Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.
PANSS General Psychopathology subscale measures symptoms of schizophrenia and consists of responses to 16 items (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS General Psychopathology subscale sums the scores from all 16 items and ranges from 16 to 112, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Outcome measures
| Measure |
Asenapine 5 mg BID
n=115 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=110 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=123 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Change From Baseline in PANSS General Psychopathology Subscale Score
Day 7
|
-4.0 Score on a scale
Standard Error 0.46
|
-3.3 Score on a scale
Standard Error 0.48
|
-2.1 Score on a scale
Standard Error 0.46
|
|
Change From Baseline in PANSS General Psychopathology Subscale Score
Day 14
|
-4.5 Score on a scale
Standard Error 0.57
|
-4.6 Score on a scale
Standard Error 0.59
|
-2.4 Score on a scale
Standard Error 0.56
|
|
Change From Baseline in PANSS General Psychopathology Subscale Score
Day 21
|
-5.5 Score on a scale
Standard Error 0.61
|
-4.9 Score on a scale
Standard Error 0.62
|
-2.9 Score on a scale
Standard Error 0.59
|
SECONDARY outcome
Timeframe: Baseline and Day 7, Day 14, Day 21Population: Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.
PANSS Marder Factor Positive symptom score measures symptoms of schizophrenia and consists of responses to 8 items (P1,P3,P5,P6,N7,G1,G9,G12). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Positive symptom score sums the scores from all 8 items and ranges from 8 to 56, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Outcome measures
| Measure |
Asenapine 5 mg BID
n=115 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=110 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=123 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Change From Baseline in PANSS Marder Factor Positive Symptom Score
Day 7
|
-1.9 Score on a scale
Standard Error 0.29
|
-1.9 Score on a scale
Standard Error 0.29
|
-1.3 Score on a scale
Standard Error 0.28
|
|
Change From Baseline in PANSS Marder Factor Positive Symptom Score
Day 14
|
-1.6 Score on a scale
Standard Error 0.33
|
-2.5 Score on a scale
Standard Error 0.34
|
-1.6 Score on a scale
Standard Error 0.33
|
|
Change From Baseline in PANSS Marder Factor Positive Symptom Score
Day 21
|
-2.6 Score on a scale
Standard Error 0.34
|
-2.9 Score on a scale
Standard Error 0.35
|
-1.7 Score on a scale
Standard Error 0.33
|
SECONDARY outcome
Timeframe: Baseline and Day 7, Day 14, Day 21Population: Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.
PANSS Marder Factor Negative symptom score measures symptoms of schizophrenia and consists of responses to 7 items (N1,N2,N3,N4,N6,G7,G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Negative symptom score sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Outcome measures
| Measure |
Asenapine 5 mg BID
n=115 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=110 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=123 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Change From Baseline in PANSS Marder Factor Negative Symptom Score
Day 7
|
-0.5 Score on a scale
Standard Error 0.23
|
-0.8 Score on a scale
Standard Error 0.24
|
-0.5 Score on a scale
Standard Error 0.23
|
|
Change From Baseline in PANSS Marder Factor Negative Symptom Score
Day 14
|
-0.6 Score on a scale
Standard Error 0.24
|
-0.5 Score on a scale
Standard Error 0.25
|
-0.7 Score on a scale
Standard Error 0.24
|
|
Change From Baseline in PANSS Marder Factor Negative Symptom Score
Day 21
|
-0.1 Score on a scale
Standard Error 0.27
|
0.1 Score on a scale
Standard Error 0.28
|
-0.1 Score on a scale
Standard Error 0.27
|
SECONDARY outcome
Timeframe: Baseline and Day 7, Day 14, Day 21Population: Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.
PANSS Marder Factor Disorganized Thought symptom score measures symptoms of schizophrenia and consists of responses to 7 items (P2,N5,G5,G10,G11,G13,G15). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Disorganized Thought symptom score sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Outcome measures
| Measure |
Asenapine 5 mg BID
n=115 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=110 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=123 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score
Day 7
|
-1.1 Score on a scale
Standard Error 0.21
|
-1.3 Score on a scale
Standard Error 0.22
|
-0.7 Score on a scale
Standard Error 0.21
|
|
Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score
Day 14
|
-1.5 Score on a scale
Standard Error 0.26
|
-1.8 Score on a scale
Standard Error 0.27
|
-1.2 Score on a scale
Standard Error 0.26
|
|
Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score
Day 21
|
-2.0 Score on a scale
Standard Error 0.28
|
-1.7 Score on a scale
Standard Error 0.29
|
-1.5 Score on a scale
Standard Error 0.27
|
SECONDARY outcome
Timeframe: Baseline and Day 7, Day 14, Day 21Population: Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.
PANSS Marder Factor Hostility/Excitement symptom score measures symptoms of schizophrenia and consists of responses to 4 items (P4,P7,G8,G14). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Hostility/Excitement symptom score sums the score from all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Outcome measures
| Measure |
Asenapine 5 mg BID
n=115 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=110 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=123 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score
Day 7
|
-1.7 Score on a scale
Standard Error 0.24
|
-1.7 Score on a scale
Standard Error 0.25
|
-0.9 Score on a scale
Standard Error 0.24
|
|
Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score
Day 14
|
-1.8 Score on a scale
Standard Error 0.28
|
-2.0 Score on a scale
Standard Error 0.29
|
-1.2 Score on a scale
Standard Error 0.27
|
|
Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score
Day 21
|
-2.6 Score on a scale
Standard Error 0.29
|
-2.5 Score on a scale
Standard Error 0.30
|
-1.5 Score on a scale
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Baseline and Day 7, Day14, Day 21Population: Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.
PANSS Marder Factor Anxiety/Depression symptom score measures symptoms of schizophrenia and consists of responses to 4 items (G2,G3,G4,G6). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Anxiety/Depression symptom score sums the scores from all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.
Outcome measures
| Measure |
Asenapine 5 mg BID
n=115 Participants
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=110 Participants
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=123 Participants
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score
Day 7
|
-1.7 Score on a scale
Standard Error 0.24
|
-1.3 Score on a scale
Standard Error 0.24
|
-0.7 Score on a scale
Standard Error 0.23
|
|
Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score
Day 14
|
-2.0 Score on a scale
Standard Error 0.26
|
-1.7 Score on a scale
Standard Error 0.27
|
-0.7 Score on a scale
Standard Error 0.26
|
|
Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score
Day 21
|
-2.1 Score on a scale
Standard Error 0.30
|
-1.9 Score on a scale
Standard Error 0.30
|
-1.0 Score on a scale
Standard Error 0.29
|
Adverse Events
Asenapine 5 mg BID
Asenapine 10 mg BID
Placebo BID
Serious adverse events
| Measure |
Asenapine 5 mg BID
n=122 participants at risk
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=119 participants at risk
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=126 participants at risk
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.82%
1/122 • Number of events 1 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
0.00%
0/119 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
0.00%
0/126 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/122 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
0.00%
0/119 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
0.79%
1/126 • Number of events 1 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/122 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
0.00%
0/119 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
0.79%
1/126 • Number of events 1 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/122 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
0.00%
0/119 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
0.79%
1/126 • Number of events 1 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
|
Psychiatric disorders
Bipolar I disorder
|
1.6%
2/122 • Number of events 2 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
0.00%
0/119 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
0.79%
1/126 • Number of events 1 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
|
Psychiatric disorders
Mania
|
0.82%
1/122 • Number of events 1 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
0.00%
0/119 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
0.00%
0/126 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/122 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
0.84%
1/119 • Number of events 1 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
0.00%
0/126 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/122 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
0.84%
1/119 • Number of events 1 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
0.00%
0/126 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
Other adverse events
| Measure |
Asenapine 5 mg BID
n=122 participants at risk
Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
|
Asenapine 10 mg BID
n=119 participants at risk
Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
|
Placebo BID
n=126 participants at risk
Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
|
|---|---|---|---|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
12.3%
15/122 • Number of events 15 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
22.7%
27/119 • Number of events 28 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
1.6%
2/126 • Number of events 2 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
|
Gastrointestinal disorders
Nausea
|
3.3%
4/122 • Number of events 4 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
5.0%
6/119 • Number of events 6 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
3.2%
4/126 • Number of events 6 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.82%
1/122 • Number of events 1 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
5.9%
7/119 • Number of events 7 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
2.4%
3/126 • Number of events 3 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
|
Nervous system disorders
Akathisia
|
4.1%
5/122 • Number of events 5 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
15.1%
18/119 • Number of events 25 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
0.79%
1/126 • Number of events 1 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
|
Nervous system disorders
Dizziness
|
3.3%
4/122 • Number of events 5 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
5.0%
6/119 • Number of events 6 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
4.8%
6/126 • Number of events 6 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
|
Nervous system disorders
Dysgeusia
|
3.3%
4/122 • Number of events 4 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
9.2%
11/119 • Number of events 11 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
0.00%
0/126 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
|
Nervous system disorders
Headache
|
7.4%
9/122 • Number of events 10 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
5.0%
6/119 • Number of events 7 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
7.1%
9/126 • Number of events 11 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
|
Nervous system disorders
Sedation
|
9.8%
12/122 • Number of events 12 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
15.1%
18/119 • Number of events 19 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
1.6%
2/126 • Number of events 2 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
|
Nervous system disorders
Somnolence
|
9.8%
12/122 • Number of events 12 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
11.8%
14/119 • Number of events 15 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
2.4%
3/126 • Number of events 3 • Up to 33 days after end of treatment (up to 54 days)
Randomized participants who received at least one dose of trial medication
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees to provide to the sponsor 45 days to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including without limitation, slides and texts of oral or other public presentations and texts of any transmission through any electronic media, eg, any computer access system such as the Internet, World Wide Web, etc) that report any results of the trial.
- Publication restrictions are in place
Restriction type: OTHER