MK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0249-016)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00506077
First received: July 24, 2007
Last updated: August 18, 2014
Last verified: August 2014
Results First Received: October 13, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Paranoid Schizophrenia
Interventions: Drug: MK0249
Drug: Comparator: Placebo (unspecified)

  Participant Flow


  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
MK0249 Then Placebo These subjects received MK0249 during Treatment Period 1 and Placebo during Treatment Period 2.
Placebo Then MK0249 These subjects received Placebo during Treatment Period 1 and MK0249 during Treatment Period 2.
Total Total of all reporting groups

Baseline Measures
    MK0249 Then Placebo     Placebo Then MK0249     Total  
Number of Participants  
[units: participants]
  28     27     55  
Age  
[units: years]
Mean ± Standard Deviation
  30.7  ± 7.5     32.5  ± 8.4     31.6  ± 7.9  
Gender  
[units: participants]
     
Female     8     7     15  
Male     20     20     40  



  Outcome Measures
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1.  Primary:   Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.   [ Time Frame: Baseline and 4 weeks of treatment ]

2.  Secondary:   Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score   [ Time Frame: Baseline and 4 weeks of treatment ]

3.  Secondary:   Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score   [ Time Frame: Baseline and 4 weeks of treatment ]

4.  Secondary:   Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score   [ Time Frame: Baseline and 4 weeks of treatment ]

5.  Other Pre-specified:   Pre-randomization Baseline: Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.   [ Time Frame: Pre-randomization Baseline ]

6.  Other Pre-specified:   Pre-randomization Baseline: Attention/Processing Speed Composite Score   [ Time Frame: Pre-randomization Baseline ]

7.  Other Pre-specified:   Pre-randomization Baseline: Episodic Memory Composite Score   [ Time Frame: Pre-randomization Baseline ]

8.  Other Pre-specified:   Pre-randomization Baseline: Working Memory Composite Score   [ Time Frame: Pre-randomization Baseline ]


  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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