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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Comparator: Placebo; Drug: MK5757

Study type: Interventional

Funder types: Industry

Identifiers

NCT00848484

2007_603

5757-005

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: Male

Ages: 21 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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54 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

MK5757

Treatment:

Drug: MK5757

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: Placebo