MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0557-027)

Schizophrenia Clinical Trial

Official title:

A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, 2-Period, Cross-Over Clinical Trial to Study the Safety and Efficacy of MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00482430
• Other study ID #: 0557-027
• Secondary ID: MK0557-0272007_5
• Status: Completed
• Phase: Phase 2
• First received: May 31, 2007
• Last updated: August 20, 2015
• Start date: September 2007
• Est. completion date: October 2008

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and effectiveness of an investigational drug for the treatment of cognitive impairment in patients with schizophrenia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• Patient is clinically stable, on current antipsychotic medication for at least 3 months and current dose for 2 months

• Patient has a 6th grade reading level or better and has completed at least 6 years of formal education

• Females are not pregnant, and those who can have children agree to remain abstinent or use acceptable birth control throughout study

• Patient has had a stable living arrangement for at least 3 months prior to study start

• Patient is in general good health based on screening assessments

Exclusion Criteria:

• Patient has a major disease/disorder that may interfere with cognitive testing (such as mental retardation) and/or pose a risk upon study participation

• Patient has a history of head trauma with loss of consciousness greater than 15 minutes

• Patient has had warfarin treatment, MAO inhibitors, clonazepam, clozapine or St. John's wort within 1 month of screening

• Patient has had ECT treatment within 6 months of screening

• Patient requires treatment with antihistamines or certain other medications listed in the protocol

• Patient has a history of liver disease that has been active within the last 2 years, or a history of cancer within past 5 years

• Patient has a history of alcohol or drug dependence within past year or alcohol or drug abuse within 3 months of screening

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Paranoid Schizophrenia
• Schizophrenia
• Schizophrenia, Paranoid

Intervention

Drug:
• MK0557
MK0557 10mg tablet qd for a 15-wk treatment period
• Comparator: Placebo (unspecified)
MK0557 Pbo tablet qd for a 15-wk treatment period

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline at 4 weeks of treatment on a sequence of cognitive tests and that MK0557 generally well tolerated		at 4 weeks of treatment	No
Secondary	Mean change from baseline at 4 weeks of treatment on neuropsychological tests for executive functioning, episodic memory and working memory		at 4 weeks of treatment	No