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Completed

NCT Number: NCT00506077

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

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.

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Key information

Conditions

Paranoid Schizophrenia Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia, Paranoid

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK0249

Drug

MK0249 10mg (2 x 5 mg) tablet daily (qd) for 28 days.

Comparator: Placebo (Unspecified)

Drug

MK0249 10mg (2 x 5 mg) Pbo tablet qd for a 28 day treatment period.

Primary outcomes

  1. 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

    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 outcomes

  1. Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score

    Time frame: Baseline and 4 weeks of treatment

    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.

  2. Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score

    Time frame: Baseline and 4 weeks of treatment

    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.

  3. Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score

    Time frame: Baseline and 4 weeks of treatment

    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 outcomes

  1. Pre-randomization Baseline: Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.

    Time frame: Pre-randomization Baseline

    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).

  2. Pre-randomization Baseline: Attention/Processing Speed Composite Score

    Time frame: Pre-randomization Baseline

    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).

  3. Pre-randomization Baseline: Episodic Memory Composite Score

    Time frame: Pre-randomization Baseline

    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).

  4. Pre-randomization Baseline: Working Memory Composite Score

    Time frame: Pre-randomization Baseline

    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).

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 25, 2007
Registry last updated
Aug 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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