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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01349907
First received: May 5, 2011
Last updated: February 24, 2015
Last verified: February 2015
Results First Received: February 24, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Bipolar Disorder
Interventions: Drug: Asenapine
Drug: Rescue medication

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants with a diagnosis of bipolar I disorder who completed the 3-week base trial P06107 (NCT01224485).

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
Asenapine/Asenapine 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.
Placebo/Asenapine 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.

Participant Flow:   Overall Study
    Asenapine/Asenapine     Placebo/Asenapine  
STARTED     241 [1]   81 [1]
COMPLETED     102     38  
NOT COMPLETED     139     43  
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



  Baseline Characteristics
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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.
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.

Reporting Groups
  Description
Asenapine/Asenapine 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.
Placebo/Asenapine 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 Total of all reporting groups

Baseline Measures
    Asenapine/Asenapine     Placebo/Asenapine     Total  
Number of Participants  
[units: participants]
  241     80     321  
Age  
[units: Years]
Mean ± Standard Deviation
  13.8  ± 2.0     13.7  ± 2.0     13.8  ± 2.0  
Gender  
[units: Participants]
     
Female     113     47     160  
Male     128     33     161  



  Outcome Measures
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1.  Primary:   Number of Participants Who Experienced Clinical or Laboratory Adverse Events   [ Time Frame: Baseline (Day 1) to 30 days after the last dose of study drug (up to approximately 54 weeks) ]

2.  Secondary:   Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score   [ Time Frame: Baseline, Day 182 and Day 350 ]

3.  Secondary:   Percentage of Participants Who Were Y-MRS Total Score Remitters (Y-MRS ≤12)   [ Time Frame: Up to Day 350 ]

4.  Secondary:   Percentage of Participants Who Were Y-MRS Total Score Responders   [ Time Frame: Up to Day 350 ]

5.  Secondary:   Time to First Total Y-MRS 50% Response   [ Time Frame: Up to Day 350 ]

6.  Secondary:   Time to Failure to Maintain Response in Y-MRS Total Score   [ Time Frame: Up to Day 350 ]

7.  Secondary:   Change From Baseline in Clinical Global Impression Scale for Assessing Overall Bipolar Illness (CGI-BP Overall)   [ Time Frame: Baseline, Day 182 and Day 350 ]

8.  Secondary:   Change From Baseline in Clinical Global Impression Scale for Assessing Depression (CGI-BP Depression)   [ Time Frame: Baseline, Day 182 and Day 350 ]

9.  Secondary:   Change From Baseline in Clinical Global Impression Scale for Assessing Mania (CGI-BP Mania)   [ Time Frame: Baseline, Day 182 and Day 350 ]

10.  Secondary:   Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score   [ Time Frame: Baseline, Day 182 and Day 350 ]

11.  Secondary:   Percentage of CDRS-R Responders   [ Time Frame: Up to Day 350 ]

12.  Secondary:   Percentage of Participants With Emergent Depression Based on CDRS-R   [ Time Frame: Up to Day 350 ]

13.  Secondary:   Change From Baseline in Children's Global Assessment Scale (CGAS)   [ Time Frame: Baseline, Day 182 and Day 350 ]

14.  Secondary:   Percentage of Participants With a CGAS Score of Equal or Greater Than 70   [ Time Frame: Up to Day 350 ]

15.  Secondary:   Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaires (PQ-LES-Q) Total Score   [ Time Frame: Baseline, Day 182 and Day 350 ]

16.  Secondary:   Change From Baseline in PQ-LES-Q Overall Score   [ Time Frame: Baseline, Day 182 and Day 350 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01349907     History of Changes
Other Study ID Numbers: P05898, MK-8274-022
Study First Received: May 5, 2011
Results First Received: February 24, 2015
Last Updated: February 24, 2015
Health Authority: United States: Food and Drug Administration