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MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia.

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00482430
First received: May 31, 2007
Last updated: November 4, 2008
Last verified: November 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 ]
Not Provided
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 ]
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Paranoid Schizophrenia
  • Schizophrenia
  • 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
  • 1
    MK0557 10mg tablet qd, crossing over to MK0557 Pbo tablet qd.
    Interventions:
    • Drug: MK0557
    • Drug: Comparator: Placebo (unspecified)
  • 2
    MK0557 Pbo tablet qd, crossing over to MK0557 10mg tablet qd.
    Interventions:
    • Drug: MK0557
    • Drug: Comparator: Placebo (unspecified)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
Not Provided
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
Not Provided
 
NCT00482430
2007_520, MK0557-027
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck
Not Provided
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