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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00506077
First received: July 24, 2007
Last updated: February 10, 2011
Last verified: February 2011
History of Changes
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
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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
First Patient Dosed: 11 February 2008; Last Patient Last Treatment: 08 October 2008. Six ex-U.S. study centers (3 Russia, 3 India).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
At visit 1, patients were assessed using the protocol eligibility criteria. Eligible patients continued into an 8 day single-blind placebo washout/run-in period, and then were randomized at visit 3 to 1 of 2 cross-over treatment sequences.

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.

Participant Flow for 3 periods

 Period 1:   Treatment Period 1
    MK0249 Then Placebo     Placebo Then MK0249  
STARTED     28     27  
COMPLETED     24     24  
NOT COMPLETED     4     3  
Adverse Event                 2                 1  
Lost to Follow-up                 0                 2  
Withdrawal by Subject                 2                 0  

Period 2:   Washout
    MK0249 Then Placebo     Placebo Then MK0249  
STARTED     24     24  
COMPLETED     24     24  
NOT COMPLETED     0     0  

Period 3:   Treatment Period 2
    MK0249 Then Placebo     Placebo Then MK0249  
STARTED     24     24  
COMPLETED     23     23  
NOT COMPLETED     1     1  
Adverse Event                 0                 1  
Withdrawal by Subject                 1                 0  



  Baseline Characteristics
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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 ]
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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 ]
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3.  Secondary:   Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score   [ Time Frame: Baseline and 4 weeks of treatment ]
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4.  Secondary:   Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score   [ Time Frame: Baseline and 4 weeks of treatment ]
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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 ]
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6.  Other Pre-specified:   Pre-randomization Baseline: Attention/Processing Speed Composite Score   [ Time Frame: Pre-randomization Baseline ]
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7.  Other Pre-specified:   Pre-randomization Baseline: Episodic Memory Composite Score   [ Time Frame: Pre-randomization Baseline ]
  Show Outcome Measure 7

8.  Other Pre-specified:   Pre-randomization Baseline: Working Memory Composite Score   [ Time Frame: Pre-randomization Baseline ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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