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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Paranoid Schizophrenia

Treatments: Drug: MK0249; Drug: Comparator: Placebo (unspecified)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00506077

0249-016

2007_522

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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55 participants in 2 patient groups, including a placebo group

MK0249

Experimental group

Treatment:

Drug: MK0249

Placebo

Placebo Comparator group

Treatment:

Drug: Comparator: Placebo (unspecified)