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

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Drug: MK5757

• Registration Number: NCT00848484
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-02-19
• Study First Submitted QC: 2009-02-19
• Study First Posted: 2009-02-20
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2010-06-11
• Results First Submitted QC: 2010-11-17
• Results First Posted: 2010-12-15
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-30
• Last Update Posted: 2015-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	MK5757	MK5757

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in the Composite Score From the Brief Assessment of Cognition in Schizophrenia (BACS) Battery After 2 Weeks of Treatment	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 Outcome Measures

Name	Time	Method
Mean Change From Baseline After 2 Weeks of Treatment in the CogState Composite Score	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.
Mean Change From Baseline After 2 Weeks of Treatment in the Attention/Processing Speed Composite Score	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.
Mean Change From Baseline After 2 Weeks of Treatment in the Episodic Memory Composite Score	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.
Mean Change From Baseline After 2 Weeks of Treatment in the Executive Functioning Composite Score	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.
Mean Change From Baseline After 2 Weeks of Treatment in the Working Memory Composite Score	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.