| May 31, 2007 |
| November 4, 2008 |
| September 2007 |
| October 2008 (final data collection date for primary outcome measure) |
| 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 ] |
| Same as current |
| Complete list of historical versions of study NCT00482430 on ClinicalTrials.gov Archive Site |
| 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 ] |
| Same as current |
| |
| MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia. |
| 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 |
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. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
- Paranoid Schizophrenia
- Schizophrenia
|
- Drug: MK0557
- Drug: Comparator: Placebo (unspecified)
|
- Other: MK0557 10mg tablet qd, crossing over to MK0557 Pbo tablet qd.
- Other: MK0557 Pbo tablet qd, crossing over to MK0557 10mg tablet qd.
|
| |
| |
| Completed |
| 50 |
|
| October 2008 (final data collection date for primary outcome measure) |
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
|
| Both |
| 21 Years to 55 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00482430 |
| Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| 2007_520, MK0557-027 |
| Merck |
|
| Study Director: |
Medical Monitor |
Merck |
|
|
| Merck |
| November 2008 |