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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
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paranoid Schizophrenia focused on measuring Undifferentiated schizophrenia, Residual schizophrenia

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 31, 2007
    Last Updated
    August 20, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    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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