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40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(COMPLETED)(P05786)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00145509
First received: September 1, 2005
Last updated: May 21, 2010
Last verified: May 2010
History of Changes
Results First Received: March 26, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Bipolar Disorder
Interventions: Drug: Asenapine
Drug: Placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Asenapine Asenapine 5 or 10 mg sublingually twice daily (BID)
Placebo Placebo sublingually BID

Participant Flow:   Overall Study
    Asenapine     Placebo  
STARTED     41     36  
COMPLETED     19     15  
NOT COMPLETED     22     21  
Adverse Event                 10                 3  
Lack of Efficacy                 3                 1  
Lost to Follow-up                 5                 9  
Withdrew Consent                 2                 7  
Reason not provided                 2                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Asenapine Asenapine 5 or 10 mg sublingually twice daily (BID)
Placebo Placebo sublingually BID
Total Total of all reporting groups

Baseline Measures
    Asenapine     Placebo     Total  
Number of Participants  
[units: participants]
 		  41     36     77  
Age  
[units: years]
Mean ± Standard Deviation 		  39.0  ± 11.79     38.7  ± 13.42     38.9  ± 12.49  
Gender  
[units: participants]
 		     
Female     16     18     34  
Male     25     18     43  



  Outcome Measures
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1.  Primary:   Number of Participants Who Experienced an Adverse Event   [ Time Frame: up to 52 weeks ]
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2.  Primary:   Number of Participants Who Discontinued Because of an Adverse Event   [ Time Frame: 40 weeks ]
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3.  Primary:   Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score   [ Time Frame: Baseline and 52 Weeks ]
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Measure Type Primary
Measure Title Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score
Measure Description The Y-MRS is an 11-item, clinician-rated instrument used for assessing the symptoms of mania. Y-MRS total score range = 0-60; higher scores indicate greater severity of symptoms.
Time Frame Baseline and 52 Weeks  
Safety Issue No  

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.
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Reporting Groups
  Description
Asenapine Asenapine 5 or 10 mg sublingually twice daily (BID)
Placebo Placebo sublingually BID

Measured Values
    Asenapine     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  41     36  
Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score  
[units: Score on a Scale]
Mean ± Standard Deviation 		  -17.2  ± 13.65     -19.7  ± 11.81  

No statistical analysis provided for Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score



4.  Primary:   Change From Baseline to Week 52 on the Montgomery Asberg Depression Rating Scale (MADRS) Score   [ Time Frame: Baseline and 52 Weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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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Results Point of Contact:  
Name/Title: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com


No publications provided


Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00145509     History of Changes
Other Study ID Numbers: A7501009, P05786
Study First Received: September 1, 2005
Results First Received: March 26, 2010
Last Updated: May 21, 2010
Health Authority: United States: Food and Drug Administration