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

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: NCT01244815
Recruitment Status : Completed
First Posted : November 19, 2010
Results First Posted : September 4, 2014
Last Update Posted : July 2, 2017
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


  Baseline Characteristics


  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
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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 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: July 2, 2017