Trial Outcomes & Findings for Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107 Has an Extension [P05898; NCT01349907])(P06107) (NCT NCT01244815)
NCT ID: NCT01244815
Last Updated: 2024-06-20
Results Overview
The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. A severity rating is assigned to each of the 11 items (Elevated mood, Increased motor activity-energy, Sexual interest, Sleep, Irritability, Speech, Language-thought disorder, Thought content, Disruptive-aggressive behavior, Appearance, Insight), based on the participant's subjective report of his or her condition over the previous 48 hours and the clinician's observations during the interview, with the emphasis on the latter. Seven of the 11 items are rated on a scale of 0-4 and 4 of the items are rated on a scale of 0-8, with higher scores indicating greater severity of symptoms. The Y-MRS total score for each participant is the sum of the ratings for the 11 individual items, and can range from 0-60, with higher scores indicating greater severity of symptoms. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.
COMPLETED
PHASE3
404 participants
Baseline and Day 21
2024-06-20
Participant Flow
Participant milestones
| Measure |
Placebo
Participants receive placebo twice daily (BID) for 21 days.
|
Asenapine 2.5 mg BID
Participants receive asenapine 2.5 mg BID for 21 days.
|
Asenapine 5.0 mg BID
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
|
Asenapine 10.0 mg BID
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
101
|
105
|
99
|
99
|
|
Overall Study
Treated
|
101
|
104
|
99
|
99
|
|
Overall Study
COMPLETED
|
87
|
88
|
88
|
87
|
|
Overall Study
NOT COMPLETED
|
14
|
17
|
11
|
12
|
Reasons for withdrawal
| Measure |
Placebo
Participants receive placebo twice daily (BID) for 21 days.
|
Asenapine 2.5 mg BID
Participants receive asenapine 2.5 mg BID for 21 days.
|
Asenapine 5.0 mg BID
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
|
Asenapine 10.0 mg BID
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
|
|---|---|---|---|---|
|
Overall Study
Not Treated
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
4
|
7
|
5
|
5
|
|
Overall Study
Treatment Failure
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
3
|
|
Overall Study
Protocol Violation
|
7
|
4
|
3
|
1
|
|
Overall Study
Did Not Meet Protocol Eligibility
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107 Has an Extension [P05898; NCT01349907])(P06107)
Baseline characteristics by cohort
| Measure |
Placebo
n=101 Participants
Participants receive placebo BID for 21 days.
|
Asenapine 2.5 mg BID
n=104 Participants
Participants receive asenapine 2.5 mg BID for 21 days.
|
Asenapine 5.0 mg BID
n=99 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
|
Asenapine 10.0 mg BID
n=99 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
|
Total
n=403 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
13.7 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
13.7 years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
13.8 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
13.9 years
STANDARD_DEVIATION 2.1 • n=4 Participants
|
13.8 years
STANDARD_DEVIATION 2.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
212 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
191 Participants
n=21 Participants
|
|
Young Mania Rating Scale (Y-MRS) total score
|
29.9 score on a scale
STANDARD_DEVIATION 5.5 • n=5 Participants
|
29.5 score on a scale
STANDARD_DEVIATION 5.7 • n=7 Participants
|
30.3 score on a scale
STANDARD_DEVIATION 5.9 • n=5 Participants
|
30.2 score on a scale
STANDARD_DEVIATION 5.6 • n=4 Participants
|
30.0 score on a scale
STANDARD_DEVIATION 5.7 • n=21 Participants
|
|
Clinical Global Impression Scale for use in Bipolar Disorder (CGI-BP) overall score
|
4.3 score on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
4.5 score on a scale
STANDARD_DEVIATION 0.6 • n=7 Participants
|
4.4 score on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
4.4 score on a scale
STANDARD_DEVIATION 0.6 • n=4 Participants
|
4.4 score on a scale
STANDARD_DEVIATION 0.6 • n=21 Participants
|
|
CGI-BP mania score
|
4.3 score on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
4.5 score on a scale
STANDARD_DEVIATION 0.6 • n=7 Participants
|
4.4 score on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
4.4 score on a scale
STANDARD_DEVIATION 0.6 • n=4 Participants
|
4.4 score on a scale
STANDARD_DEVIATION 0.6 • n=21 Participants
|
|
CGI-BP depression score
|
2.9 score on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
2.8 score on a scale
STANDARD_DEVIATION 1.3 • n=7 Participants
|
2.9 score on a scale
STANDARD_DEVIATION 1.4 • n=5 Participants
|
2.8 score on a scale
STANDARD_DEVIATION 1.2 • n=4 Participants
|
2.8 score on a scale
STANDARD_DEVIATION 1.3 • n=21 Participants
|
|
Children's Depression Rating Scale, Revised (CDRS-R) total score
|
34.5 score on a scale
STANDARD_DEVIATION 10.2 • n=5 Participants
|
33.7 score on a scale
STANDARD_DEVIATION 9.0 • n=7 Participants
|
35.2 score on a scale
STANDARD_DEVIATION 11.9 • n=5 Participants
|
34.1 score on a scale
STANDARD_DEVIATION 9.0 • n=4 Participants
|
34.4 score on a scale
STANDARD_DEVIATION 10.1 • n=21 Participants
|
|
Children's Global Assessment Scale (CGAS) total score - current functioning
|
49.0 score on a scale
STANDARD_DEVIATION 7.9 • n=5 Participants
|
49.6 score on a scale
STANDARD_DEVIATION 7.4 • n=7 Participants
|
48.4 score on a scale
STANDARD_DEVIATION 7.4 • n=5 Participants
|
49.1 score on a scale
STANDARD_DEVIATION 6.7 • n=4 Participants
|
49.0 score on a scale
STANDARD_DEVIATION 7.4 • n=21 Participants
|
|
Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) total score
|
48.7 score on a scale
STANDARD_DEVIATION 9.7 • n=5 Participants
|
49.1 score on a scale
STANDARD_DEVIATION 9.6 • n=7 Participants
|
49.5 score on a scale
STANDARD_DEVIATION 9.1 • n=5 Participants
|
49.1 score on a scale
STANDARD_DEVIATION 10.5 • n=4 Participants
|
49.1 score on a scale
STANDARD_DEVIATION 9.7 • n=21 Participants
|
|
PQ-LES-Q overall score (i.e., item 15)
|
3.7 score on a scale
STANDARD_DEVIATION 1.0 • n=5 Participants
|
3.8 score on a scale
STANDARD_DEVIATION 1.0 • n=7 Participants
|
3.8 score on a scale
STANDARD_DEVIATION 0.9 • n=5 Participants
|
3.8 score on a scale
STANDARD_DEVIATION 1.0 • n=4 Participants
|
3.8 score on a scale
STANDARD_DEVIATION 1.0 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 21Population: Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy Full Analysis Set \[FAS\]); also, to be included an on-treatment Day 21 value of Y-MRS total score must be available for a participant.
The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. A severity rating is assigned to each of the 11 items (Elevated mood, Increased motor activity-energy, Sexual interest, Sleep, Irritability, Speech, Language-thought disorder, Thought content, Disruptive-aggressive behavior, Appearance, Insight), based on the participant's subjective report of his or her condition over the previous 48 hours and the clinician's observations during the interview, with the emphasis on the latter. Seven of the 11 items are rated on a scale of 0-4 and 4 of the items are rated on a scale of 0-8, with higher scores indicating greater severity of symptoms. The Y-MRS total score for each participant is the sum of the ratings for the 11 individual items, and can range from 0-60, with higher scores indicating greater severity of symptoms. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Placebo
n=79 Participants
Participants receive placebo BID for 21 days.
|
Asenapine 2.5 mg BID
n=88 Participants
Participants receive asenapine 2.5 mg BID for 21 days.
|
Asenapine 5.0 mg BID
n=87 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
|
Asenapine 10.0 mg BID
n=81 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in Y-MRS Total Score at Day 21
|
-9.6 score on a scale
Standard Deviation 7.8
|
-12.3 score on a scale
Standard Deviation 9.0
|
-15.1 score on a scale
Standard Deviation 9.5
|
-15.9 score on a scale
Standard Deviation 9.1
|
SECONDARY outcome
Timeframe: Baseline and Day 21Population: Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 21 value of CGI-BP overall score must be available for a participant.
Change from baseline in CGI-BP overall score at Day 21 is the Key Secondary Outcome Measure. The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the participant's overall bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Placebo
n=79 Participants
Participants receive placebo BID for 21 days.
|
Asenapine 2.5 mg BID
n=88 Participants
Participants receive asenapine 2.5 mg BID for 21 days.
|
Asenapine 5.0 mg BID
n=87 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
|
Asenapine 10.0 mg BID
n=81 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in Clinical Global Impression Scale for Use in Bipolar Disorder (CGI-BP) Overall Score at Day 21
|
-0.7 score on a scale
Standard Deviation 0.9
|
-1.3 score on a scale
Standard Deviation 1.1
|
-1.4 score on a scale
Standard Deviation 1.0
|
-1.4 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline and Days 4, 7, 14 and 21Population: Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included for a visit, a Y-MRS total score must be available for that visit or a prior post-baseline on-treatment visit
A total Y-MRS 50% responder was defined as a participant who had a reduction from baseline to the identified study visit of at least 50% in the Y-MRS total score. The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. A severity rating is assigned to each of the 11 items, based on the participant's subjective report of his or her condition over the previous 48 hours and the clinician's observations during the interview, with the emphasis on the latter. The Y-MRS total score for each participant is the sum of the ratings for the 11 individual items, and can range from 0-60 with higher scores indicating greater severity of symptoms. This analysis used a Last-Observation-Carried-Forward (LOCF) approach; if at a given visit no Y-MRS total score was available for determining whether a participant was a responder, the last available post-baseline on-treatment assessment prior to that visit was used.
Outcome measures
| Measure |
Placebo
n=98 Participants
Participants receive placebo BID for 21 days.
|
Asenapine 2.5 mg BID
n=101 Participants
Participants receive asenapine 2.5 mg BID for 21 days.
|
Asenapine 5.0 mg BID
n=98 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
|
Asenapine 10.0 mg BID
n=98 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
|
|---|---|---|---|---|
|
Total Y-MRS 50% Responders at Days 4, 7, 14 and 21
Day 7 (n=98, 101, 98, 98)
|
14 participants
|
33 participants
|
31 participants
|
37 participants
|
|
Total Y-MRS 50% Responders at Days 4, 7, 14 and 21
Day 4 (n=95, 98, 93, 90)
|
7 participants
|
19 participants
|
20 participants
|
13 participants
|
|
Total Y-MRS 50% Responders at Days 4, 7, 14 and 21
Day 14 (n=98, 101, 98, 98)
|
20 participants
|
36 participants
|
50 participants
|
50 participants
|
|
Total Y-MRS 50% Responders at Days 4, 7, 14 and 21
Day 21 (n=98, 101, 98, 98)
|
27 participants
|
42 participants
|
53 participants
|
51 participants
|
SECONDARY outcome
Timeframe: Baseline and Day 4Population: Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 4 value of CGI-BP mania score must be available for a participant.
The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the mania component of the participant's bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 4; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Placebo
n=93 Participants
Participants receive placebo BID for 21 days.
|
Asenapine 2.5 mg BID
n=97 Participants
Participants receive asenapine 2.5 mg BID for 21 days.
|
Asenapine 5.0 mg BID
n=93 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
|
Asenapine 10.0 mg BID
n=90 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in CGI-BP Mania Score at Day 4
|
-0.3 score on a scale
Standard Deviation 0.6
|
-0.6 score on a scale
Standard Deviation 0.8
|
-0.5 score on a scale
Standard Deviation 0.7
|
-0.5 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline and Day 7Population: Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 7 value of CGI-BP mania score must be available for a participant.
The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the mania component of the participant's bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 7; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Placebo
n=95 Participants
Participants receive placebo BID for 21 days.
|
Asenapine 2.5 mg BID
n=98 Participants
Participants receive asenapine 2.5 mg BID for 21 days.
|
Asenapine 5.0 mg BID
n=95 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
|
Asenapine 10.0 mg BID
n=97 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in CGI-BP Mania Score at Day 7
|
-0.5 score on a scale
Standard Deviation 0.7
|
-0.9 score on a scale
Standard Deviation 0.9
|
-0.9 score on a scale
Standard Deviation 1.0
|
-0.9 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline and Day 14Population: Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 14 value of CGI-BP mania score must be available for a participant.
The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the mania component of the participant's bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 14; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Placebo
n=89 Participants
Participants receive placebo BID for 21 days.
|
Asenapine 2.5 mg BID
n=91 Participants
Participants receive asenapine 2.5 mg BID for 21 days.
|
Asenapine 5.0 mg BID
n=90 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
|
Asenapine 10.0 mg BID
n=91 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in CGI-BP Mania Score at Day 14
|
-0.6 score on a scale
Standard Deviation 1.0
|
-1.1 score on a scale
Standard Deviation 1.0
|
-1.4 score on a scale
Standard Deviation 1.0
|
-1.3 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline and Day 21Population: Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 21 value of CGI-BP mania score must be available for a participant.
The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the mania component of the participant's bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Placebo
n=79 Participants
Participants receive placebo BID for 21 days.
|
Asenapine 2.5 mg BID
n=88 Participants
Participants receive asenapine 2.5 mg BID for 21 days.
|
Asenapine 5.0 mg BID
n=87 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
|
Asenapine 10.0 mg BID
n=81 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in CGI-BP Mania Score at Day 21
|
-0.7 score on a scale
Standard Deviation 0.9
|
-1.3 score on a scale
Standard Deviation 1.1
|
-1.5 score on a scale
Standard Deviation 1.1
|
-1.4 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline and Day 4Population: Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 4 value of CGI-BP depression score must be available for a participant.
The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the depression component of the participant's bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 4; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Placebo
n=92 Participants
Participants receive placebo BID for 21 days.
|
Asenapine 2.5 mg BID
n=97 Participants
Participants receive asenapine 2.5 mg BID for 21 days.
|
Asenapine 5.0 mg BID
n=93 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
|
Asenapine 10.0 mg BID
n=90 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in CGI-BP Depression Score at Day 4
|
-0.2 score on a scale
Standard Deviation 0.7
|
-0.3 score on a scale
Standard Deviation 0.8
|
-0.2 score on a scale
Standard Deviation 1.0
|
-0.1 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline and Day 7Population: Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 7 value of CGI-BP depression score must be available for a participant.
The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the depression component of the participant's bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 7; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Placebo
n=94 Participants
Participants receive placebo BID for 21 days.
|
Asenapine 2.5 mg BID
n=98 Participants
Participants receive asenapine 2.5 mg BID for 21 days.
|
Asenapine 5.0 mg BID
n=95 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
|
Asenapine 10.0 mg BID
n=97 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in CGI-BP Depression Score at Day 7
|
-0.4 score on a scale
Standard Deviation 0.9
|
-0.5 score on a scale
Standard Deviation 0.8
|
-0.5 score on a scale
Standard Deviation 1.1
|
-0.5 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline and Day 14Population: Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 14 value of CGI-BP depression score must be available for a participant.
The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the depression component of the participant's bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 14; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Placebo
n=88 Participants
Participants receive placebo BID for 21 days.
|
Asenapine 2.5 mg BID
n=91 Participants
Participants receive asenapine 2.5 mg BID for 21 days.
|
Asenapine 5.0 mg BID
n=90 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
|
Asenapine 10.0 mg BID
n=91 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in CGI-BP Depression Score at Day 14
|
-0.5 score on a scale
Standard Deviation 1.1
|
-0.5 score on a scale
Standard Deviation 1.0
|
-0.7 score on a scale
Standard Deviation 1.0
|
-0.6 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline and Day 21Population: Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 21 value of CGI-BP depression score must be available for a participant.
The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the depression component of the participant's bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants receive placebo BID for 21 days.
|
Asenapine 2.5 mg BID
n=88 Participants
Participants receive asenapine 2.5 mg BID for 21 days.
|
Asenapine 5.0 mg BID
n=87 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
|
Asenapine 10.0 mg BID
n=81 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in CGI-BP Depression Score at Day 21
|
-0.4 score on a scale
Standard Deviation 1.0
|
-0.6 score on a scale
Standard Deviation 1.1
|
-0.8 score on a scale
Standard Deviation 1.1
|
-0.6 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline and Day 7Population: Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 7 value of CDRS-R total score must be available for a participant.
The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. Fourteen of the 17 items are rated on a scale of 1-7 and 3 of the items are rated on a scale of 1-5, with higher scores indicating greater severity of symptoms. The CDRS-R total score for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. The reported measure is the change from baseline at Day 7; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Placebo
n=94 Participants
Participants receive placebo BID for 21 days.
|
Asenapine 2.5 mg BID
n=95 Participants
Participants receive asenapine 2.5 mg BID for 21 days.
|
Asenapine 5.0 mg BID
n=91 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
|
Asenapine 10.0 mg BID
n=95 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score at Day 7
|
-4.1 score on a scale
Standard Deviation 8.1
|
-6.1 score on a scale
Standard Deviation 7.1
|
-6.1 score on a scale
Standard Deviation 8.0
|
-5.9 score on a scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: Baseline and Day 14Population: Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 14 value of CDRS-R total score must be available for a participant.
The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. Fourteen of the 17 items are rated on a scale of 1-7 and 3 of the items are rated on a scale of 1-5, with higher scores indicating greater severity of symptoms. The CDRS-R total score for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. The reported measure is the change from baseline at Day 14; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Placebo
n=88 Participants
Participants receive placebo BID for 21 days.
|
Asenapine 2.5 mg BID
n=89 Participants
Participants receive asenapine 2.5 mg BID for 21 days.
|
Asenapine 5.0 mg BID
n=90 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
|
Asenapine 10.0 mg BID
n=90 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in CDRS-R Total Score at Day 14
|
-5.5 score on a scale
Standard Deviation 8.1
|
-5.8 score on a scale
Standard Deviation 6.5
|
-8.7 score on a scale
Standard Deviation 10.5
|
-6.6 score on a scale
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: Baseline and Day 21Population: Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 21 value of CDRS-R total score must be available for a participant.
The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. Fourteen of the 17 items are rated on a scale of 1-7 and 3 of the items are rated on a scale of 1-5, with higher scores indicating greater severity of symptoms. The CDRS-R total score for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants receive placebo BID for 21 days.
|
Asenapine 2.5 mg BID
n=87 Participants
Participants receive asenapine 2.5 mg BID for 21 days.
|
Asenapine 5.0 mg BID
n=87 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
|
Asenapine 10.0 mg BID
n=81 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in CDRS-R Total Score at Day 21
|
-6.1 score on a scale
Standard Deviation 8.8
|
-6.9 score on a scale
Standard Deviation 7.3
|
-8.7 score on a scale
Standard Deviation 11.4
|
-6.8 score on a scale
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: Baseline and Day 21Population: Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of CGAS score must be available for a participant.
CGAS is a 100-point scale measuring psychological, social, and school functioning in children aged 6-17. Minimum scores ranged from 1-10, representing the need for constant supervision (worse result) to maximum scores of 91-100, representing superior functioning (better result). The reported measure is the change from baseline at Day 21; improvement in functioning is represented by positive values. This analysis used an LOCF approach; if no Day 21 value was available for a participant, the last available post-baseline on-treatment assessment prior to the Day 21 assessment was used.
Outcome measures
| Measure |
Placebo
n=84 Participants
Participants receive placebo BID for 21 days.
|
Asenapine 2.5 mg BID
n=93 Participants
Participants receive asenapine 2.5 mg BID for 21 days.
|
Asenapine 5.0 mg BID
n=91 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
|
Asenapine 10.0 mg BID
n=85 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Day 21
|
6.0 score on a scale
Standard Deviation 8.1
|
9.4 score on a scale
Standard Deviation 9.5
|
13.0 score on a scale
Standard Deviation 11.6
|
10.8 score on a scale
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: Baseline and Day 21Population: Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of PQ-LES-Q total score must be available for a participant.
PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The PQ-LES-Q total score for each participant was calculated as the sum of the rating assigned to each of the first 14 items, and ranged from 14 to 70 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 21; improvement in quality of life is represented by positive values. This analysis used an LOCF approach; if no Day 21 value was available for a participant, the last available post-baseline on-treatment assessment prior to the Day 21 assessment was used.
Outcome measures
| Measure |
Placebo
n=84 Participants
Participants receive placebo BID for 21 days.
|
Asenapine 2.5 mg BID
n=92 Participants
Participants receive asenapine 2.5 mg BID for 21 days.
|
Asenapine 5.0 mg BID
n=90 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
|
Asenapine 10.0 mg BID
n=84 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score at Day 21
|
1.5 score on a scale
Standard Deviation 8.2
|
3.7 score on a scale
Standard Deviation 8.6
|
2.5 score on a scale
Standard Deviation 10.8
|
4.0 score on a scale
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: Baseline and Day 21Population: Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of PQ-LES-Q overall score must be available for a participant.
PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The Item 15 result is defined to be the PQ-LES-Q overall score, and ranged from 1 to 5 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 21; improvement in quality of life is represented by positive values. This analysis used an LOCF approach; if no Day 21 value was available for a participant, the last available post-baseline on-treatment assessment prior to the Day 21 assessment was used.
Outcome measures
| Measure |
Placebo
n=84 Participants
Participants receive placebo BID for 21 days.
|
Asenapine 2.5 mg BID
n=92 Participants
Participants receive asenapine 2.5 mg BID for 21 days.
|
Asenapine 5.0 mg BID
n=90 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
|
Asenapine 10.0 mg BID
n=84 Participants
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in PQ-LES-Q Overall Score (i.e., Item 15) at Day 21
|
-0.0 score on a scale
Standard Deviation 0.9
|
0.4 score on a scale
Standard Deviation 1.0
|
0.1 score on a scale
Standard Deviation 1.0
|
0.2 score on a scale
Standard Deviation 1.1
|
Adverse Events
Placebo
Asenapine 2.5 mg BID
Asenapine 5.0 mg BID
Asenapine 10.0 mg BID
Serious adverse events
| Measure |
Placebo
n=101 participants at risk
Participants receive placebo BID for 21 days.
|
Asenapine 2.5 mg BID
n=104 participants at risk
Participants receive asenapine 2.5 mg BID for 21 days.
|
Asenapine 5.0 mg BID
n=99 participants at risk
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
|
Asenapine 10.0 mg BID
n=99 participants at risk
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
|
|---|---|---|---|---|
|
Psychiatric disorders
BIPOLAR DISORDER
|
0.99%
1/101 • Number of events 1 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
0.00%
0/104 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
0.00%
0/99 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
1.0%
1/99 • Number of events 1 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
|
Psychiatric disorders
BIPOLAR I DISORDER
|
0.99%
1/101 • Number of events 1 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
0.00%
0/104 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
1.0%
1/99 • Number of events 1 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
0.00%
0/99 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
|
Psychiatric disorders
MANIA
|
0.00%
0/101 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
0.00%
0/104 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
1.0%
1/99 • Number of events 1 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
0.00%
0/99 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
|
Psychiatric disorders
SUICIDAL BEHAVIOUR
|
0.99%
1/101 • Number of events 1 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
0.00%
0/104 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
0.00%
0/99 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
0.00%
0/99 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.99%
1/101 • Number of events 1 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
0.00%
0/104 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
0.00%
0/99 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
0.00%
0/99 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/101 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
0.00%
0/104 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
0.00%
0/99 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
1.0%
1/99 • Number of events 1 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
Other adverse events
| Measure |
Placebo
n=101 participants at risk
Participants receive placebo BID for 21 days.
|
Asenapine 2.5 mg BID
n=104 participants at risk
Participants receive asenapine 2.5 mg BID for 21 days.
|
Asenapine 5.0 mg BID
n=99 participants at risk
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
|
Asenapine 10.0 mg BID
n=99 participants at risk
Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.9%
6/101 • Number of events 6 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
4.8%
5/104 • Number of events 5 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
2.0%
2/99 • Number of events 2 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
3.0%
3/99 • Number of events 3 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
|
Gastrointestinal disorders
HYPOAESTHESIA ORAL
|
2.0%
2/101 • Number of events 2 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
17.3%
18/104 • Number of events 18 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
18.2%
18/99 • Number of events 19 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
20.2%
20/99 • Number of events 21 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
|
Gastrointestinal disorders
NAUSEA
|
3.0%
3/101 • Number of events 3 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
5.8%
6/104 • Number of events 6 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
6.1%
6/99 • Number of events 6 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
6.1%
6/99 • Number of events 7 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
|
Gastrointestinal disorders
PARAESTHESIA ORAL
|
2.0%
2/101 • Number of events 2 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
8.7%
9/104 • Number of events 9 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
9.1%
9/99 • Number of events 9 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
11.1%
11/99 • Number of events 11 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
|
General disorders
FATIGUE
|
5.0%
5/101 • Number of events 5 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
3.8%
4/104 • Number of events 4 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
8.1%
8/99 • Number of events 8 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
13.1%
13/99 • Number of events 13 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/101 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
5.8%
6/104 • Number of events 6 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
2.0%
2/99 • Number of events 2 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
2.0%
2/99 • Number of events 2 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
|
Metabolism and nutrition disorders
INCREASED APPETITE
|
2.0%
2/101 • Number of events 2 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
9.6%
10/104 • Number of events 10 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
9.1%
9/99 • Number of events 10 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
6.1%
6/99 • Number of events 6 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
|
Nervous system disorders
DIZZINESS
|
3.0%
3/101 • Number of events 4 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
5.8%
6/104 • Number of events 6 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
10.1%
10/99 • Number of events 11 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
5.1%
5/99 • Number of events 5 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
|
Nervous system disorders
DYSGEUSIA
|
2.0%
2/101 • Number of events 2 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
3.8%
4/104 • Number of events 4 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
5.1%
5/99 • Number of events 5 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
9.1%
9/99 • Number of events 9 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
|
Nervous system disorders
HEADACHE
|
5.9%
6/101 • Number of events 6 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
7.7%
8/104 • Number of events 11 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
11.1%
11/99 • Number of events 12 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
9.1%
9/99 • Number of events 10 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
|
Nervous system disorders
SEDATION
|
5.0%
5/101 • Number of events 5 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
15.4%
16/104 • Number of events 16 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
19.2%
19/99 • Number of events 19 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
18.2%
18/99 • Number of events 20 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
|
Nervous system disorders
SOMNOLENCE
|
5.9%
6/101 • Number of events 6 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
32.7%
34/104 • Number of events 39 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
34.3%
34/99 • Number of events 36 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
31.3%
31/99 • Number of events 34 • Up to 30 days after the last dose of study drug (Up to 51 days)
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
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