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

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

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

• 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

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