6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the Protocol 25543 (25544)(P05777)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00265343
First received: December 12, 2005
Last updated: July 15, 2014
Last verified: July 2014
Results First Received: February 17, 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: Schizophrenia
Interventions: Drug: asenapine
Drug: olanzapine

  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
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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 5-10 mg twice daily (bid) sublingual (SL)
Olanzapine 5-20 mg daily (QD) orally (PO)

Participant Flow:   Overall Study
    Asenapine     Olanzapine  
STARTED     134     172  
COMPLETED     113     153  
NOT COMPLETED     21     19  
Adverse Event                 10                 7  
Withdrawal by Subject                 3                 9  
Unknown                 8                 3  



  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.
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Reporting Groups
  Description
Asenapine 5-10 mg twice daily (bid) sublingual (SL)
Olanzapine 5-20 mg daily (QD) orally (PO)
Total Total of all reporting groups

Baseline Measures
    Asenapine     Olanzapine     Total  
Number of Participants  
[units: participants]
  134     172     306  
Age  
[units: years]
Mean ± Standard Deviation
  39.9  ± 12.2     40.7  ± 11.7     40.4  ± 11.9  
Gender  
[units: participants]
     
Female     43     53     96  
Male     91     119     210  



  Outcome Measures
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1.  Primary:   Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale   [ Time Frame: Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544) ]

2.  Secondary:   Change in Quality of Life Measured by Quality of Life Scale (QLS)   [ Time Frame: Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544) ]


  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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00265343     History of Changes
Other Study ID Numbers: P05777, 25544, Aphrodite
Study First Received: December 12, 2005
Results First Received: February 17, 2010
Last Updated: July 15, 2014
Health Authority: Finland: Finnish Medicines Agency