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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00848484 |
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Date of registration:
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19/02/2009 |
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Primary sponsor: |
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Public title:
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Treatment of Cognitive Impairment in Men With Schizophrenia (MK5757-005)(COMPLETED)
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Scientific title:
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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 |
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Date of first enrolment:
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October 2008 |
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Target sample size:
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54 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00848484 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Russian Federation
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United States
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Merck |
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Key inclusion & exclusion criteria
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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
Age minimum:
21 Years
Age maximum:
55 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Schizophrenia
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Intervention(s)
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Drug: Comparator: Placebo
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Drug: MK5757
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Mean Change From Baseline After 2 Weeks of Treatment in the Attention/Processing Speed Composite Score
[Time Frame: Baseline and Week 2]
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Mean Change From Baseline After 2 Weeks of Treatment in the CogState Composite Score
[Time Frame: Baseline and week 2]
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Mean Change From Baseline After 2 Weeks of Treatment in the Episodic Memory Composite Score
[Time Frame: Baseline and Week 2]
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Mean Change From Baseline After 2 Weeks of Treatment in the Executive Functioning Composite Score
[Time Frame: Baseline and Week 2]
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Mean Change From Baseline After 2 Weeks of Treatment in the Working Memory Composite Score
[Time Frame: Baseline and Week 2]
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Secondary ID(s)
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2007_603
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MK-5757-005
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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