MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia.
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00482430
First received: May 31, 2007
Last updated: November 4, 2008
Last verified: November 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Paranoid Schizophrenia Schizophrenia |
Drug: MK0557 Drug: Comparator: Placebo (unspecified) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | September 2007 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
MK0557 10mg tablet qd, crossing over to MK0557 Pbo tablet qd.
|
Drug: MK0557
MK0557 10mg tablet qd for a 15-wk treatment period
Drug: Comparator: Placebo (unspecified)
MK0557 Pbo tablet qd for a 15-wk treatment period
|
|
2
MK0557 Pbo tablet qd, crossing over to MK0557 10mg tablet qd.
|
Drug: MK0557
MK0557 10mg tablet qd for a 15-wk treatment period
Drug: Comparator: Placebo (unspecified)
MK0557 Pbo tablet qd for a 15-wk treatment period
|
Eligibility| Ages Eligible for Study: | 21 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| ClinicalTrials.gov Identifier: | NCT00482430 History of Changes |
| Other Study ID Numbers: | 2007_520, MK0557-027 |
| Study First Received: | May 31, 2007 |
| Last Updated: | November 4, 2008 |
| Health Authority: | Malaysia: Ministry of Health |
Keywords provided by Merck:
|
Undifferentiated schizophrenia Residual schizophrenia |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia, Paranoid Cognition Disorders |
Schizophrenia and Disorders with Psychotic Features Mental Disorders Delirium, Dementia, Amnestic, Cognitive Disorders |
ClinicalTrials.gov processed this record on June 17, 2013