Treatment of Cognitive Impairment in Men With Schizophrenia. - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00848484

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: MK5757 Drug: Comparator: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

To evaluate the effectiveness of MK5757 compared to placebo in improving executive functioning at 2 weeks of treatment as measured by the mean change from baseline on the composite score from specific neuropsychological tests. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the effectiveness of MK5757 compared to placebo in improving working memory at 2 weeks of treatment as measured by the change from baseline on the memory composite score of certain neuropsychological tests. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	65
Study Start Date:	October 2008
Study Completion Date:	July 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MK5757	Drug: MK5757 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 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
2: Placebo Comparator Placebo	Drug: Comparator: Placebo 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 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.

Eligibility

Ages Eligible for Study:	21 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848484

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_603, MK5757-005
Study First Received:	February 19, 2009
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00848484 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 30, 2009