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Completed

NCT Number: NCT00848484

Treatment of Cognitive Impairment in Men With Schizophrenia (MK5757-005)(COMPLETED)

This study is to evaluate the safety and efficacy of the study drug compared to placebo in the treatment of cognitive impairment in men with schizophrenia.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

21 year–55 year

Sex eligibility

Male

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 male between 21 and 55 years of age
  • Duration of the illness must be longer than 1 year
  • Patient's current antipsychotic medication regimen must be stable
  • Patient is negative for selected drugs of abuse at Screening
  • Must be in a stable living arrangement for at least 3 months prior to screening (not a homeless shelter)

Exclusion criteria

  • Patient has mental retardation
  • Undergone Electroconvulsive Therapy (ECT) treatment within 6 months prior to screening
  • Has suicidal attempts or ideation within the last 12 months
  • Patient has a history of alcohol/drug dependence within 1 year or alcohol/drug abuse within 12 months of starting the study

Treatment and study plan

MK5757

Drug

This is a 2 period, cross-over study. In each of the two treatment periods, each patient will receive the following: Days 1 and 28 MK5757 25 mg capsules three times a day (tid). Days 2 through 14 and Days 29 through 42 MK5757 50 mg capsules tid. Study drug is taken 3 times daily. Each treatment period is 14 days

Comparator: placebo

Drug

This is a 2 period, cross-over study. In each of the two treatment periods, each patient will receive the following: Days 1 and 28 MK5757 one placebo capsules three times a day (tid). Days 2 through 14 and Days 29 through 42 two MK5757 placebo capsules tid. Study drug is taken 3 times daily. Each treatment period is 14 days.

Primary outcomes

  1. Mean Change From Baseline in the Composite Score From the Brief Assessment of Cognition in Schizophrenia (BACS) Battery After 2 Weeks of Treatment

    Time frame: Baseline and Week 2

    The Brief Assessment of Cognition in Schizophrenia (BACS) was used to evaluate cognitive impairment, as measured by the mean change from baseline after 2 weeks of treatment in the composite score. The BACS composite score was calculated by averaging scores from the BACS subtests, including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Verbal Fluency (Semantic Fluency and Letter Fluency) and Tower of London. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -111.5 and 111.5, respectively.

Secondary outcomes

  1. Mean Change From Baseline After 2 Weeks of Treatment in the CogState Composite Score

    Time frame: Baseline and week 2

    CogState Schizophrenia Battery was used to evaluate cognitive impairment, as measured by the mean change from baseline after 2 weeks of treatment in the composite score. The composite score was comprised of 4 modules from the CogState Schizophrenia Battery: Identification Task, Detection Task, One Card Learning Task and Groton Maze Learning Task. Composite score was calculated by averaging all available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at 2 weeks of treatment for the endpoint are -347.5 and 347.5, respectively.

  2. Mean Change From Baseline After 2 Weeks of Treatment in the Executive Functioning Composite Score

    Time frame: Baseline and Week 2

    The Executive Functioning Composite Score was comprised of the following tests: Groton Maze Learning Task from the CogState Schizophrenia Battery and Tower of London, Semantic Fluency and Letter Fluency tests from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -253.4 and 253.4, respectively.

  3. Mean Change From Baseline After 2 Weeks of Treatment in the Episodic Memory Composite Score

    Time frame: Baseline and Week 2

    The Episodic Memory Composite Score was comprised of the following tests: Continuous Paired Associate Learning Task and One Card Learning Task from the CogState Schizophrenia Battery and the Verbal Memory test from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -207.06 and 207.06, respectively.

  4. Mean Change From Baseline After 2 Weeks of Treatment in the Working Memory Composite Score

    Time frame: Baseline and Week 2

    The Working Memory Composite Score was comprised of the following tests: Two-Back Memory Task from the CogState Schizophrenia Battery and the Digit Sequencing test from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -27.06 and 27.06, respectively.

  5. Mean Change From Baseline After 2 Weeks of Treatment in the Attention/Processing Speed Composite Score

    Time frame: Baseline and Week 2

    The Attention/Processing Speed Composite Score was comprised of the following tests: Identification Task and the Detection Task from the CogState Schizophrenia Battery and the Symbol Coding test from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -287.15 and 287.15, respectively.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Add-On Therapy, 2-Period Cross-Over Clinical Trial to Evaluate the Safety and Efficacy of MK5757 for the Treatment of Cognitive Impairment in Men With Schizophrenia

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 20, 2009
Registry last updated
Nov 2, 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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