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

Study 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.

Official Title
-----------------
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

Conditions
-----------------
Paranoid Schizophrenia, Schizophrenia

Intervention / Treatment
-----------------
* Drug: MK0557
* Drug: Comparator: Placebo (unspecified)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>MK0557 10mg tablet qd, crossing over to MK0557 Pbo tablet qd. | Drug: MK0557<br>* MK0557 10mg tablet qd for a 15-wk treatment period<br>Drug: Comparator: Placebo (unspecified)<br>* MK0557 Pbo tablet qd for a 15-wk treatment period<br>|
| Other: 2<br>MK0557 Pbo tablet qd, crossing over to MK0557 10mg tablet qd. | Drug: MK0557<br>* MK0557 10mg tablet qd for a 15-wk treatment period<br>Drug: Comparator: Placebo (unspecified)<br>* MK0557 Pbo tablet qd for a 15-wk treatment period<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Undifferentiated schizophrenia, Residual schizophrenia