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Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107 Has an Extension [P05898; NCT01349907])(P06107)

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ClinicalTrials.gov Identifier: NCT01244815
Recruitment Status : Completed
First Posted : November 19, 2010
Results First Posted : September 4, 2014
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Bipolar Disorder, Pediatric
Interventions: Drug: asenapine
Drug: Placebo to match asenapine
Drug: Rescue medication

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Placebo   Asenapine 2.5 mg BID   Asenapine 5.0 mg BID   Asenapine 10.0 mg BID
STARTED   101 [1]   105 [1]   99 [1]   99 [1] 
Treated   101   104   99   99 
COMPLETED   87   88   88   87 
NOT COMPLETED   14   17   11   12 
Not Treated                0                1                0                0 
Adverse Event                4                7                5                5 
Treatment Failure                0                0                0                1 
Lost to Follow-up                3                2                3                2 
Withdrawal by Subject                0                2                0                3 
Protocol Violation                7                4                3                1 
Did Not Meet Protocol Eligibility                0                1                0                0 
[1] Randomized



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The population consisted of all randomized participants who received at least one dose of study drug.

Reporting Groups
  Description
Placebo Participants receive placebo 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.
Total Total of all reporting groups

Baseline Measures
   Placebo   Asenapine 2.5 mg BID   Asenapine 5.0 mg BID   Asenapine 10.0 mg BID   Total 
Overall Participants Analyzed 
[Units: Participants]
 101   104   99   99   403 
Age 
[Units: Years]
Mean (Standard Deviation)
 13.7  (2.0)   13.7  (2.1)   13.8  (2.0)   13.9  (2.1)   13.8  (2.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      63  62.4%      52  50.0%      56  56.6%      41  41.4%      212  52.6% 
Male      38  37.6%      52  50.0%      43  43.4%      58  58.6%      191  47.4% 
Young Mania Rating Scale (Y-MRS) total score [1] 
[Units: Score on a scale]
Mean (Standard Deviation)
 29.9  (5.5)   29.5  (5.7)   30.3  (5.9)   30.2  (5.6)   30.0  (5.7) 
[1] Y-MRS is an 11-item instrument for assessing the severity of manic episodes. Seven of the 11 items are rated on a scale of 0-4 and 4 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. Summary statistics presented are for efficacy population (Full Analysis Set [FAS]): N=98, 101, 98, 98 and 395 for Placebo, asenapine 2.5 mg BID, asenapine 5.0 mg BID, asenapine 10.0 mg BID and Total groups, respectively.
Clinical Global Impression Scale for use in Bipolar Disorder (CGI-BP) overall score [1] 
[Units: Score on a scale]
Mean (Standard Deviation)
 4.3  (0.5)   4.5  (0.6)   4.4  (0.6)   4.4  (0.6)   4.4  (0.6) 
[1] CGI-BP overall score is obtained using 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. Summary statistics presented are for efficacy population (FAS): N=98, 101, 98, 98 and 395 for Placebo, asenapine 2.5 mg BID, asenapine 5.0 mg BID, asenapine 10.0 mg BID and Total groups, respectively.
CGI-BP mania score [1] 
[Units: Score on a scale]
Mean (Standard Deviation)
 4.3  (0.5)   4.5  (0.6)   4.4  (0.6)   4.4  (0.6)   4.4  (0.6) 
[1] CGI-BP mania score is obtained using 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. Summary statistics presented are for efficacy population (FAS): N=98, 101, 98, 98 and 395 for Placebo, asenapine 2.5 mg BID, asenapine 5.0 mg BID, asenapine 10.0 mg BID and Total groups, respectively.
CGI-BP depression score [1] 
[Units: Score on a scale]
Mean (Standard Deviation)
 2.9  (1.3)   2.8  (1.3)   2.9  (1.4)   2.8  (1.2)   2.8  (1.3) 
[1] CGI-BP depression score is obtained using 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. Summary statistics presented are for efficacy population (FAS) except as noted: N=97 (baseline value not available for 1 FAS participant in this group), 101, 98, 98 and 394 for Placebo, asenapine 2.5 mg BID, asenapine 5.0 mg BID, asenapine 10.0 mg BID and Total groups, respectively.
Children's Depression Rating Scale, Revised (CDRS-R) total score [1] 
[Units: Score on a scale]
Mean (Standard Deviation)
 34.5  (10.2)   33.7  (9.0)   35.2  (11.9)   34.1  (9.0)   34.4  (10.1) 
[1] CDRS-R is a 17-item instrument for assessing depression in children. Items are rated on a scale of 1-7 (14 items) or 1-5 (3 items); higher scores indicate more severe symptoms. CDRS-R total score is sum of ratings for the 17 items (range: 17-113). Summary statistics presented are for efficacy population (FAS) except as noted: N=97 (baseline value not available for 1 FAS participant in this group), 99 (baseline value not available for 2 FAS participants in this group), 98, 98 and 392 for Placebo, asenapine 2.5 mg BID, asenapine 5.0 mg BID, asenapine 10.0 mg BID and Total groups, respectively.
Children’s Global Assessment Scale (CGAS) total score - current functioning [1] 
[Units: Score on a scale]
Mean (Standard Deviation)
 49.0  (7.9)   49.6  (7.4)   48.4  (7.4)   49.1  (6.7)   49.0  (7.4) 
[1] 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). Summary statistics presented are for efficacy population (Full Analysis Set [FAS]): N=98, 101, 98, 98 and 395 for Placebo, asenapine 2.5 mg BID, asenapine 5.0 mg BID, asenapine 10.0 mg BID and Total groups, respectively.
Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) total score [1] 
[Units: Score on a scale]
Mean (Standard Deviation)
 48.7  (9.7)   49.1  (9.6)   49.5  (9.1)   49.1  (10.5)   49.1  (9.7) 
[1] 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 on a scale of 1=very poor to 5=very good. The PQ-LES-Q total score (sum of Items 1-14) ranged from 14 to 70 with a higher score indicating better quality of life. Summary statistics presented are for efficacy population (Full Analysis Set [FAS]): N=98, 101, 98, 98 and 395 for Placebo, asenapine 2.5 mg BID, asenapine 5.0 mg BID, asenapine 10.0 mg BID and Total groups, respectively.
PQ-LES-Q overall score (i.e., item 15) [1] 
[Units: Score on a scale]
Mean (Standard Deviation)
 3.7  (1.0)   3.8  (1.0)   3.8  (0.9)   3.8  (1.0)   3.8  (1.0) 
[1] 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 on a scale of 1=very poor to 5=very good. The PQ-LES-Q overall score (Item 15, a global assessment of quality of life) ranged from 1 to 5 with a higher score indicating better quality of life. Summary statistics presented are for efficacy population (Full Analysis Set [FAS]): N=98, 101, 98, 98 and 395 for Placebo, asenapine 2.5 mg BID, asenapine 5.0 mg BID, asenapine 10.0 mg BID and Total groups, respectively.


  Outcome Measures

1.  Primary:   Change From Baseline in Y-MRS Total Score at Day 21   [ Time Frame: Baseline and Day 21 ]

2.  Secondary:   Change From Baseline in Clinical Global Impression Scale for Use in Bipolar Disorder (CGI-BP) Overall Score at Day 21   [ Time Frame: Baseline and Day 21 ]

3.  Secondary:   Total Y-MRS 50% Responders at Days 4, 7, 14 and 21   [ Time Frame: Baseline and Days 4, 7, 14 and 21 ]

4.  Secondary:   Change From Baseline in CGI-BP Mania Score at Day 4   [ Time Frame: Baseline and Day 4 ]

5.  Secondary:   Change From Baseline in CGI-BP Mania Score at Day 7   [ Time Frame: Baseline and Day 7 ]

6.  Secondary:   Change From Baseline in CGI-BP Mania Score at Day 14   [ Time Frame: Baseline and Day 14 ]

7.  Secondary:   Change From Baseline in CGI-BP Mania Score at Day 21   [ Time Frame: Baseline and Day 21 ]

8.  Secondary:   Change From Baseline in CGI-BP Depression Score at Day 4   [ Time Frame: Baseline and Day 4 ]

9.  Secondary:   Change From Baseline in CGI-BP Depression Score at Day 7   [ Time Frame: Baseline and Day 7 ]

10.  Secondary:   Change From Baseline in CGI-BP Depression Score at Day 14   [ Time Frame: Baseline and Day 14 ]

11.  Secondary:   Change From Baseline in CGI-BP Depression Score at Day 21   [ Time Frame: Baseline and Day 21 ]

12.  Secondary:   Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score at Day 7   [ Time Frame: Baseline and Day 7 ]

13.  Secondary:   Change From Baseline in CDRS-R Total Score at Day 14   [ Time Frame: Baseline and Day 14 ]

14.  Secondary:   Change From Baseline in CDRS-R Total Score at Day 21   [ Time Frame: Baseline and Day 21 ]

15.  Secondary:   Change From Baseline in Children’s Global Assessment Scale (CGAS) Score at Day 21   [ Time Frame: Baseline and Day 21 ]

16.  Secondary:   Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score at Day 21   [ Time Frame: Baseline and Day 21 ]

17.  Secondary:   Change From Baseline in PQ-LES-Q Overall Score (i.e., Item 15) at Day 21   [ Time Frame: Baseline and Day 21 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01244815     History of Changes
Other Study ID Numbers: P06107
First Submitted: November 18, 2010
First Posted: November 19, 2010
Results First Submitted: August 21, 2014
Results First Posted: September 4, 2014
Last Update Posted: October 16, 2018