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

Phase 2

Completed

• Conditions: Paranoid Schizophrenia
• Interventions: Drug: MK0249

• Registration Number: NCT00506077
• Lead Sponsor: Merck Sharp & Dohme LLC

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 Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2007-07-24
• Study First Submitted QC: 2007-07-24
• Study First Posted: 2007-07-25
• Study Start: 2007-12
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2010-10-13
• Results First Submitted QC: 2011-02-10
• Results First Posted: 2011-03-07
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-31
• Last Update Posted: 2015-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Patient is clinically stable, on current antipsychotic medication for at least 3 months and current dose for 2 months
• Patient has a 6th grade reading level or better
• Females are not pregnant, and those who can have children agree to remain abstinent or use acceptable birth control throughout the study
• Patient has had a stable living arrangement for at least 3 months prior to study start
• Patient is in general good health based on screening assessments
• Patient has total Positive and Negative Syndrome Scale (PANSS) score between 36 and 75 at screening and at the first baseline visit
• Patient has a Clinical Global Impressions - Severity (CGI-S) score less than or equal to 4 at screening and at the first baseline visit

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Exclusion Criteria

• Patient has a major disease/disorder that may interfere with cognitive testing (such as mental retardation) and/or pose a risk upon study participation
• Patient has a history of head trauma with loss of consciousness greater than 15 minutes
• Patient has had warfarin treatment, MAO inhibitors, clonazepam or clozapine within 1 month of screening
• Patient has had ECT treatment within 6 months of screening
• Patient requires treatment with antihistamines or certain other medications listed in the protocol
• Patient has a history of liver disease that has been active within the last 2 years, or a history of cancer within the past 5 years
• Patient has a history of alcohol or drug dependence within the past year or alcohol or drug abuse within 3 months of screening

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MK0249	MK0249	-

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.	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.

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score	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	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	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.