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MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia.
This study has been completed.
Study NCT00482430   Information provided by Merck
First Received: May 31, 2007   Last Updated: November 4, 2008   History of Changes

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.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP