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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, 2-Period, Cross-Over Clinical Trial to Study the Safety and Efficacy of MK0249 for the Treatment of Cognitive Impairment in Patients With Sch

Brief Summary: The purpose of this study is to determine the safety and effectiveness of an investigational drug MK0249 for the treatment of the cognitive impairment in patients with schizophrenia.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome: 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 ]

The mean change from baseline after 4 weeks of treatment in total cognitive score on the BACS was calculated as a weighted average of T-scores (normalized for age) from BACS subtests including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Semantic Fluency, Letter Fluency, and Tower of London. The minimum and maximum values possible for this composite T-score of the change from baseline were -131 and 131, respectively. Higher values (positive changes from baseline) indicate better performance.


Original Primary Outcome:

Current Secondary Outcome:

  • Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score [ Time Frame: Baseline and 4 weeks of treatment ]
    The Attention/Processing Speed Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological Battery (CNP) Penn Continuous Performance Test (PCPT) and BACS battery Symbol Coding. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -91 and 91, respectively. Higher values (positive changes from baseline) indicate better performance.
  • Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score [ Time Frame: Baseline and 4 weeks of treatment ]
    The Episodic Memory Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological Battery (CNP) Face Memory and BACS battery Verbal Memory. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -202 and 202, respectively. Higher values (positive changes from baseline) indicate better performance.
  • Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score [ Time Frame: Baseline and 4 weeks of treatment ]
    The Working Memory Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological (CNP) battery N-back test and the BACS battery Digit Sequencing test. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -122 and 122, respectively. Higher values (positive changes from baseline) indicate better performance.


Original Secondary Outcome:

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: July 24, 2007
Date Started: December 2007
Date Completion:
Last Updated: July 31, 2015
Last Verified: July 2015