A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, 2-Period, Cross-Over Clinical Trial to Study the Safety and Efficacy of MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia

Merck Sharp & Dohme LLC0 sites50 target enrollmentSeptember 2007

ConditionsParanoid Schizophrenia Schizophrenia

InterventionsMK0557

DrugsMK0557 Comparator: Placebo (unspecified)

Overview

Phase: Phase 2
Intervention: MK0557
Conditions: Paranoid Schizophrenia
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 50
Primary Endpoint: Mean change from baseline at 4 weeks of treatment on a sequence of cognitive tests and that MK0557 generally well tolerated
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

October 2008

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

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

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

Arms & Interventions

1

MK0557 10mg tablet qd, crossing over to MK0557 Pbo tablet qd.

Intervention: MK0557

2

MK0557 Pbo tablet qd, crossing over to MK0557 10mg tablet qd.

Intervention: MK0557

Outcomes

Primary Outcomes

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

Time Frame: at 4 weeks of treatment

Secondary Outcomes

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)