MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0557-027)
Primary Purpose
Paranoid Schizophrenia, Schizophrenia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0557
Comparator: Placebo (unspecified)
Sponsored by
About this trial
This is an interventional treatment trial for Paranoid Schizophrenia focused on measuring Undifferentiated schizophrenia, Residual schizophrenia
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1
2
Arm Description
MK0557 10mg tablet qd, crossing over to MK0557 Pbo tablet qd.
MK0557 Pbo tablet qd, crossing over to MK0557 10mg tablet qd.
Outcomes
Primary Outcome Measures
Mean change from baseline at 4 weeks of treatment on a sequence of cognitive tests and that MK0557 generally well tolerated
Secondary Outcome Measures
Mean change from baseline at 4 weeks of treatment on neuropsychological tests for executive functioning, episodic memory and working memory
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00482430
Brief Title
MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0557-027)
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paranoid Schizophrenia, Schizophrenia
Keywords
Undifferentiated schizophrenia, Residual schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
MK0557 10mg tablet qd, crossing over to MK0557 Pbo tablet qd.
Arm Title
2
Arm Type
Other
Arm Description
MK0557 Pbo tablet qd, crossing over to MK0557 10mg tablet qd.
Intervention Type
Drug
Intervention Name(s)
MK0557
Intervention Description
MK0557 10mg tablet qd for a 15-wk treatment period
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo (unspecified)
Intervention Description
MK0557 Pbo tablet qd for a 15-wk treatment period
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Mean change from baseline at 4 weeks of treatment on neuropsychological tests for executive functioning, episodic memory and working memory
Time Frame
at 4 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0557-027)
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