MK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0249-016)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00506077
First received: July 24, 2007
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to determine the safety and effectiveness of an investigational drug MK0249 for the treatment of the cognitive impairment in patients with schizophrenia.


Condition Intervention Phase
Paranoid Schizophrenia
Drug: MK0249
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 MK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery. [ Time Frame: Baseline and 4 weeks of treatment ] [ Designated as safety issue: No ]
    The mean change from baseline after 4 weeks of treatment in total cognitive score on the BACS was calculated as a weighted average of T-scores (normalized for age) from BACS subtests including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Semantic Fluency, Letter Fluency, and Tower of London. The minimum and maximum values possible for this composite T-score of the change from baseline were -131 and 131, respectively. Higher values (positive changes from baseline) indicate better performance.


Secondary Outcome Measures:
  • Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score [ Time Frame: Baseline and 4 weeks of treatment ] [ Designated as safety issue: No ]
    The Attention/Processing Speed Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological Battery (CNP) Penn Continuous Performance Test (PCPT) and BACS battery Symbol Coding. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -91 and 91, respectively. Higher values (positive changes from baseline) indicate better performance.

  • Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score [ Time Frame: Baseline and 4 weeks of treatment ] [ Designated as safety issue: No ]
    The Episodic Memory Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological Battery (CNP) Face Memory and BACS battery Verbal Memory. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -202 and 202, respectively. Higher values (positive changes from baseline) indicate better performance.

  • Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score [ Time Frame: Baseline and 4 weeks of treatment ] [ Designated as safety issue: No ]
    The Working Memory Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological (CNP) battery N-back test and the BACS battery Digit Sequencing test. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -122 and 122, respectively. Higher values (positive changes from baseline) indicate better performance.


Other Outcome Measures:
  • Pre-randomization Baseline: Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery. [ Time Frame: Pre-randomization Baseline ] [ Designated as safety issue: No ]

    Pre-randomization baseline values for all treatment sequences are equal because

    the constrained longitudinal data analysis (cLDA) model was used

    (Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134-148).


  • Pre-randomization Baseline: Attention/Processing Speed Composite Score [ Time Frame: Pre-randomization Baseline ] [ Designated as safety issue: No ]

    Pre-randomization baseline values for all treatment sequences are equal because

    the constrained longitudinal data analysis (cLDA) model was used

    (Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134-148).


  • Pre-randomization Baseline: Episodic Memory Composite Score [ Time Frame: Pre-randomization Baseline ] [ Designated as safety issue: No ]

    Pre-randomization baseline values for all treatment sequences are equal because

    the constrained longitudinal data analysis (cLDA) model was used

    (Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134-148).


  • Pre-randomization Baseline: Working Memory Composite Score [ Time Frame: Pre-randomization Baseline ] [ Designated as safety issue: No ]

    Pre-randomization baseline values for all treatment sequences are equal because

    the constrained longitudinal data analysis (cLDA) model was used

    (Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134-148).



Enrollment: 55
Study Start Date: December 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK0249 Drug: MK0249
MK0249 10mg (2 x 5 mg) tablet daily (qd) for 28 days.
Placebo Comparator: Placebo Drug: Comparator: Placebo (unspecified)
MK0249 10mg (2 x 5 mg) Pbo tablet qd for a 28 day 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
  • Females are not pregnant, and those who can have children agree to remain abstinent or use acceptable birth control throughout the 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
  • Patient has total Positive and Negative Syndrome Scale (PANSS) score between 36 and 75 at screening and at the first baseline visit
  • Patient has a Clinical Global Impressions - Severity (CGI-S) score less than or equal to 4 at screening and at the first baseline visit

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 or clozapine 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 the past 5 years
  • Patient has a history of alcohol or drug dependence within the past year or alcohol or drug abuse within 3 months of screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506077

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00506077     History of Changes
Other Study ID Numbers: 0249-016, 2007_522
Study First Received: July 24, 2007
Results First Received: October 13, 2010
Last Updated: August 18, 2014
Health Authority: Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Merck Sharp & Dohme Corp.:
Undifferentiated schizophrenia
residual schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Cognition Disorders
Schizophrenia, Paranoid
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders

ClinicalTrials.gov processed this record on September 16, 2014