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Trial record 3 of 5 for:    asenapine bipolar pediatric

Extension Study of Asenapine [P06107 (NCT01244815)] for Pediatric Bipolar Disorder (P05898) (ADDRESS-98)

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ClinicalTrials.gov Identifier: NCT01349907
Recruitment Status : Completed
First Posted : May 9, 2011
Results First Posted : March 9, 2015
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bipolar Disorder
Interventions Drug: Asenapine
Drug: Rescue medication
Enrollment 322
Recruitment Details Participants with a diagnosis of bipolar I disorder who completed the 3-week base trial P06107 (NCT01224485).
Pre-assignment Details  
Arm/Group Title Asenapine/Asenapine Placebo/Asenapine
Hide Arm/Group Description Participants treated with asenapine in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg twice daily (BID), then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks. Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Period Title: Overall Study
Started 241 [1] 81 [1]
Completed 102 38
Not Completed 139 43
Reason Not Completed
Adverse Event             37             11
Treatment failure             13             4
Lost to Follow-up             25             6
Withdrawal by Subject             30             8
Protocol Violation             33             13
Administrative             1             1
[1]
Enrolled and Treated
Arm/Group Title Asenapine/Asenapine Placebo/Asenapine Total
Hide Arm/Group Description Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks. Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks. Total of all reporting groups
Overall Number of Baseline Participants 241 80 321
Hide Baseline Analysis Population Description
Participants who received at least one dose of trial medication, and were 17 years old or younger. One 18 year old participant from the Placebo/Asenapine group, was excluded due to being overage.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 241 participants 80 participants 321 participants
13.8  (2.0) 13.7  (2.0) 13.8  (2.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 241 participants 80 participants 321 participants
Female
113
  46.9%
47
  58.8%
160
  49.8%
Male
128
  53.1%
33
  41.3%
161
  50.2%
1.Primary Outcome
Title Number of Participants Who Experienced Clinical or Laboratory Adverse Events
Hide Description A clinical or laboratory adverse event is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
Time Frame Baseline (Day 1) to 30 days after the last dose of study drug (up to approximately 54 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of trial medication, and were 17 years old or younger. One treated participant from the Placebo/Asenapine group, who was 18 years old, was excluded from this analysis.
Arm/Group Title Asenapine/Asenapine Placebo/Asenapine
Hide Arm/Group Description:
Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Overall Number of Participants Analyzed 241 80
Measure Type: Number
Unit of Measure: Participants
197 74
2.Secondary Outcome
Title Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score
Hide Description The Y-MRS assesses the severity of manic episodes by assigning a severity rating to each of 11 items (Elevated mood, Increased motor activity-energy, Sexual interest, Sleep, Irritability, Speech, Language-thought disorder, Thought content, Disruptive-aggressive behavior, Appearance, Insight). 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. The Y-MRS total score, observed cases (OC), the assessment closest to the scheduled assessment day within the allowed window, 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. Improvement in symptoms is represented by change from baseline values that are negative.
Time Frame Baseline, Day 182 and Day 350
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.
Arm/Group Title Asenapine/Asenapine Placebo/Asenapine
Hide Arm/Group Description:
Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Overall Number of Participants Analyzed 227 72
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Day 182 (n=112, 37) -4.9  (7.8) -13.0  (8.3)
Day 350 (n=45, 20) -6.5  (10.5) -15.2  (5.8)
3.Secondary Outcome
Title Percentage of Participants Who Were Y-MRS Total Score Remitters (Y-MRS ≤12)
Hide Description The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. The Y-MRS total score, OC 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. A remitter is a participant with a Y-MRS total score of 12 or lower.
Time Frame Up to Day 350
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.
Arm/Group Title Asenapine/Asenapine Placebo/Asenapine
Hide Arm/Group Description:
Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Overall Number of Participants Analyzed 227 72
Measure Type: Number
Unit of Measure: Percentage of participants
Day 182 (n= 112, 37) 63.4 83.8
Day 350 (n = 45, 20) 75.6 90.0
4.Secondary Outcome
Title Percentage of Participants Who Were Y-MRS Total Score Responders
Hide Description The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. The Y-MRS total score, OC 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. A Y-MRS responder experiences a 50% or more decrease from baseline in Y-MRS total score.
Time Frame Up to Day 350
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.
Arm/Group Title Asenapine/Asenapine Placebo/Asenapine
Hide Arm/Group Description:
Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Overall Number of Participants Analyzed 227 72
Measure Type: Number
Unit of Measure: Percentage of participants
Day 182 (n= 111, 37) 37.8 64.9
Day 350 (n=43, 20) 53.5 80.0
5.Secondary Outcome
Title Time to First Total Y-MRS 50% Response
Hide Description The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. The Y-MRS total score, OC for each participant is the sum of the ratings for the 11 individual items, ranging from 0-60, with higher scores indicating more severe symptoms. The time to 50% response is the number of days on treatment to achieve a 50% decrease from baseline in Y-MRS total score.
Time Frame Up to Day 350
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.
Arm/Group Title Asenapine/Asenapine Placebo/Asenapine
Hide Arm/Group Description:
Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Overall Number of Participants Analyzed 227 72
Median (95% Confidence Interval)
Unit of Measure: Days
15.0
(14.0 to 21.0)
49.0
(44.0 to 50.0)
6.Secondary Outcome
Title Time to Failure to Maintain Response in Y-MRS Total Score
Hide Description The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. The Y-MRS total score, OC for each participant is the sum of the ratings for the 11 individual items, ranging from 0-60, with higher scores indicating more severe symptoms. The time to failure is the number of days from first achieving a 50% or more decrease from baseline in Y-MRS total score to the first subsequent day of a less than 50% decrease from baseline in Y-MRS total score.
Time Frame Up to Day 350
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment. Restricted to participants who were total Y-MRS 50% responders in base trial P06107.
Arm/Group Title Asenapine/Asenapine Placebo/Asenapine
Hide Arm/Group Description:
Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Overall Number of Participants Analyzed 120 21
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(268.0 to NA)
194.0 [1] 
(78.0 to NA)
[1]
NA = Not achieved after 362 days of follow-up
7.Secondary Outcome
Title Change From Baseline in Clinical Global Impression Scale for Assessing Overall Bipolar Illness (CGI-BP Overall)
Hide Description The CGI-BP overall is a single value score OC for assessing overall bipolar illness, recorded on a 7-point scale ranging from 1 for normal/not ill, to 7 for very severely ill. An improvement in symptoms is represented by change from baseline values that are negative.
Time Frame Baseline, Day 182 and Day 350
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.
Arm/Group Title Asenapine/Asenapine Placebo/Asenapine
Hide Arm/Group Description:
Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Overall Number of Participants Analyzed 227 72
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Day 182 (n=113, 37) -0.9  (1.0) -1.8  (1.1)
Day 350 (n=46, 20) -1.2  (1.3) -2.4  (1.2)
8.Secondary Outcome
Title Change From Baseline in Clinical Global Impression Scale for Assessing Depression (CGI-BP Depression)
Hide Description The CGI-BP depression is a single value score OC for assessing depression, recorded on a 7-point scale ranging from 1 for normal/not ill, to 7 for very severely ill. An improvement in symptoms is represented by change from baseline values that are negative.
Time Frame Baseline, Day 182 and Day 350
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.
Arm/Group Title Asenapine/Asenapine Placebo/Asenapine
Hide Arm/Group Description:
Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Overall Number of Participants Analyzed 227 72
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Day 182 (n=113, 37) -0.5  (0.9) -0.8  (1.2)
Day 350 (n=46, 20) -0.4  (1.0) -1.2  (1.3)
9.Secondary Outcome
Title Change From Baseline in Clinical Global Impression Scale for Assessing Mania (CGI-BP Mania)
Hide Description The CGI-BP mania is a single value score OC for assessing mania, recorded on a 7-point scale ranging from 1 for normal/not ill, to 7 for very severely ill. An improvement in symptoms is represented by change from baseline values that are negative.
Time Frame Baseline, Day 182 and Day 350
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.
Arm/Group Title Asenapine/Asenapine Placebo/Asenapine
Hide Arm/Group Description:
Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Overall Number of Participants Analyzed 227 72
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Day 182 (n=113, 37) -1.0  (1.0) -1.9  (1.1)
Day 350 (n=46, 20) -1.2  (1.3) -2.3  (1.2)
10.Secondary Outcome
Title Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score
Hide Description 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, OC 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. Improvement in symptoms is represented by change from baseline values that are negative.
Time Frame Baseline, Day 182 and Day 350
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.
Arm/Group Title Asenapine/Asenapine Placebo/Asenapine
Hide Arm/Group Description:
Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Overall Number of Participants Analyzed 227 72
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Day 182 (n=112, 37) -1.4  (6.4) -5.4  (7.5)
Day 350 (n=44, 20) -1.1  (5.5) -4.3  (6.6)
11.Secondary Outcome
Title Percentage of CDRS-R Responders
Hide Description The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. The CDRS-R total score, OC 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. A CDRS-R responder experiences a 50% or more decrease from baseline in CDRS-R total score.
Time Frame Up to Day 350
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.
Arm/Group Title Asenapine/Asenapine Placebo/Asenapine
Hide Arm/Group Description:
Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Overall Number of Participants Analyzed 227 72
Measure Type: Number
Unit of Measure: Percentage of participants
Day 182 (n=111, 37) 36.0 56.8
Day 350 (n=43, 20) 32.6 65.0
12.Secondary Outcome
Title Percentage of Participants With Emergent Depression Based on CDRS-R
Hide Description The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. The CDRS-R total score, OC 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. Participants with a CDRS-R score of 40 or greater (whose baseline CDRS-R is less than 40) exhibit emergent depression, which is a strong indicator of the presence or potential for a major depressive disorder.
Time Frame Up to Day 350
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.
Arm/Group Title Asenapine/Asenapine Placebo/Asenapine
Hide Arm/Group Description:
Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Overall Number of Participants Analyzed 227 72
Measure Type: Number
Unit of Measure: Percentage of participants
Day 182 (n=112, 37) 2.7 0.0
Day 350 (n=44, 20) 2.3 5.0
13.Secondary Outcome
Title Change From Baseline in Children's Global Assessment Scale (CGAS)
Hide Description CGAS is a scale with a possible range of 1 to 100, measuring psychological, social, and school functioning in children. Minimum scores, OC range from 1-10, representing the need for constant supervision (worse result) to maximum scores of 91-100, representing superior functioning (better result). An improvement in function is represented by a change from baseline value that is positive.
Time Frame Baseline, Day 182 and Day 350
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.
Arm/Group Title Asenapine/Asenapine Placebo/Asenapine
Hide Arm/Group Description:
Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Overall Number of Participants Analyzed 227 72
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Day 182 (n=114, 37) 9.7  (10.1) 17.4  (9.9)
Day 350 (n=46, 20) 13.1  (13.6) 22.5  (8.0)
14.Secondary Outcome
Title Percentage of Participants With a CGAS Score of Equal or Greater Than 70
Hide Description CGAS is a scale with a possible range of 1 to 100, measuring psychological, social, and school functioning in children. Minimum scores, OC range from 1-10, representing the need for constant supervision (worse result) to maximum scores of 91-100, representing superior functioning (better result). The percentage of participants with a score of 70 or greater, representing normal to superior social functioning, is shown.
Time Frame Up to Day 350
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.
Arm/Group Title Asenapine/Asenapine Placebo/Asenapine
Hide Arm/Group Description:
Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Overall Number of Participants Analyzed 227 72
Measure Type: Number
Unit of Measure: Percentage of participants
Day 182 (n=114, 37) 55.3 73.0
Day 350 (n=46, 20) 73.9 85.0
15.Secondary Outcome
Title Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaires (PQ-LES-Q) Total Score
Hide Description PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant rates 15 items reflecting quality of life from the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., health, mood or feelings); item 15 is a global assessment of overall quality of life. The PQ-LES-Q total score for each participant, OC is the sum of the rating assigned to each of the first 14 items, and ranges from 14 to 70, with a higher score indicating better quality of life. An improvement in quality of life is represented by change from baseline values that are positive.
Time Frame Baseline, Day 182 and Day 350
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.
Arm/Group Title Asenapine/Asenapine Placebo/Asenapine
Hide Arm/Group Description:
Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Overall Number of Participants Analyzed 227 72
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Day 182 (n=111, 36) 1.0  (7.1) 4.4  (8.3)
Day 350 (n=45, 20) 0.5  (7.3) 3.4  (10.9)
16.Secondary Outcome
Title Change From Baseline in PQ-LES-Q Overall Score
Hide Description PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant rates 15 items reflecting quality of life from the previous week. Item 15, the PQ-LES-Q overall score, observed OC, is a global assessment of overall quality of life, and ranges from 1 to 5, with a higher score indicating better quality of life. An improvement in quality of life is represented by change from baseline values that are positive.
Time Frame Baseline, Day 182 and Day 350
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.
Arm/Group Title Asenapine/Asenapine Placebo/Asenapine
Hide Arm/Group Description:
Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Overall Number of Participants Analyzed 227 72
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Day 182 (n=111, 36) 0.1  (0.8) 0.3  (0.8)
Day 350 (n=45, 20) 0.4  (1.0) 0.3  (0.9)
Time Frame 30 days after the last dose of study drug (up to approximately 54 weeks).
Adverse Event Reporting Description All enrolled and treated participants
 
Arm/Group Title Asenapine/Asenapine Placebo/Asenapine
Hide Arm/Group Description Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks. Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
All-Cause Mortality
Asenapine/Asenapine Placebo/Asenapine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Asenapine/Asenapine Placebo/Asenapine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/241 (7.05%)      6/81 (7.41%)    
Gastrointestinal disorders     
Swollen tongue  1  0/241 (0.00%)  0 1/81 (1.23%)  2
Immune system disorders     
Drug hypersensitivity  1  0/241 (0.00%)  0 1/81 (1.23%)  2
Injury, poisoning and procedural complications     
Accidental overdose  1  1/241 (0.41%)  1 0/81 (0.00%)  0
Intentional overdose  1  1/241 (0.41%)  1 0/81 (0.00%)  0
Nervous system disorders     
Dystonia  1  1/241 (0.41%)  1 0/81 (0.00%)  0
Loss of consciousness  1  1/241 (0.41%)  1 0/81 (0.00%)  0
Somnolence  1  1/241 (0.41%)  1 0/81 (0.00%)  0
Psychiatric disorders     
Aggression  1  2/241 (0.83%)  2 1/81 (1.23%)  2
Agitation  1  1/241 (0.41%)  1 1/81 (1.23%)  1
Anxiety  1  1/241 (0.41%)  1 0/81 (0.00%)  0
Bipolar disorder  1  2/241 (0.83%)  3 2/81 (2.47%)  2
Depression  1  3/241 (1.24%)  3 0/81 (0.00%)  0
Disturbance in social behaviour  1  1/241 (0.41%)  1 0/81 (0.00%)  0
Exhibitionism  1  1/241 (0.41%)  1 0/81 (0.00%)  0
Impulsive behaviour  1  1/241 (0.41%)  1 0/81 (0.00%)  0
Mania  1  1/241 (0.41%)  1 0/81 (0.00%)  0
Self-injurious ideation  1  1/241 (0.41%)  1 0/81 (0.00%)  0
Suicidal behaviour  1  1/241 (0.41%)  1 0/81 (0.00%)  0
Suicidal ideation  1  7/241 (2.90%)  8 1/81 (1.23%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Asenapine/Asenapine Placebo/Asenapine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   135/241 (56.02%)      65/81 (80.25%)    
Gastrointestinal disorders     
Abdominal pain upper  1  10/241 (4.15%)  15 6/81 (7.41%)  6
Hypoaesthesia oral  1  2/241 (0.83%)  2 11/81 (13.58%)  11
Nausea  1  15/241 (6.22%)  17 9/81 (11.11%)  9
Paraesthesia oral  1  3/241 (1.24%)  3 8/81 (9.88%)  10
Vomiting  1  16/241 (6.64%)  18 4/81 (4.94%)  4
General disorders     
Fatigue  1  15/241 (6.22%)  17 6/81 (7.41%)  7
Infections and infestations     
Gastroenteritis viral  1  4/241 (1.66%)  4 5/81 (6.17%)  5
Investigations     
Weight increased  1  42/241 (17.43%)  43 16/81 (19.75%)  16
Metabolism and nutrition disorders     
Increased appetite  1  16/241 (6.64%)  18 6/81 (7.41%)  6
Nervous system disorders     
Dizziness  1  5/241 (2.07%)  6 8/81 (9.88%)  10
Dysgeusia  1  4/241 (1.66%)  4 5/81 (6.17%)  5
Headache  1  21/241 (8.71%)  30 11/81 (13.58%)  21
Sedation  1  23/241 (9.54%)  29 19/81 (23.46%)  27
Somnolence  1  44/241 (18.26%)  50 29/81 (35.80%)  36
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
No publication or manuscript shall contain any trade secret information of the sponsor or any proprietary or confidential information of the sponsor, and shall be confined to new discoveries and interpretations of scientific fact.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01349907     History of Changes
Other Study ID Numbers: P05898
MK-8274-022 ( Other Identifier: Merck Protocol Number )
First Submitted: May 5, 2011
First Posted: May 9, 2011
Results First Submitted: February 24, 2015
Results First Posted: March 9, 2015
Last Update Posted: October 12, 2018