MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0557-027)

Phase 2

Completed

• Conditions: Paranoid Schizophrenia; Schizophrenia
• Interventions: Drug: MK0557

• Registration Number: NCT00482430
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this study is to determine the safety and effectiveness of an investigational drug for the treatment of 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: 2007-05-31
• Study First Submitted QC: 2007-06-01
• Study First Posted: 2007-06-05
• Study Start: 2007-09
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-20
• Last Update Posted: 2015-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 and has completed at least 6 years of formal education
• Females are not pregnant, and those who can have children agree to remain abstinent or use acceptable birth control throughout 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

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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, clozapine or St. John's wort 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 past 5 years
• Patient has a history of alcohol or drug dependence within 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
1	MK0557	MK0557 10mg tablet qd, crossing over to MK0557 Pbo tablet qd.
2	MK0557	MK0557 Pbo tablet qd, crossing over to MK0557 10mg tablet qd.

Primary Outcome Measures

Name	Time	Method
Mean change from baseline at 4 weeks of treatment on a sequence of cognitive tests and that MK0557 generally well tolerated	at 4 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline at 4 weeks of treatment on neuropsychological tests for executive functioning, episodic memory and working memory	at 4 weeks of treatment