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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01349907
Recruitment Status : Completed
First Posted : May 9, 2011
Results First Posted : March 9, 2015
Last Update Posted : October 24, 2016
Sponsor:
Information provided by (Responsible Party):

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

  Participant Flow


  Baseline Characteristics


  Outcome Measures

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

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

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

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 24, 2016