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

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00482430
• Collaborator: (none)
• Enrollment: 50
• Arms: 2
• Duration (Months): 13

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Paranoid Schizophrenia; Schizophrenia	Drug: MK0557; Drug: Comparator: Placebo (unspecified)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: 1 MK0557 10mg tablet qd, crossing over to MK0557 Pbo tablet qd.	Drug: MK0557; MK0557 10mg tablet qd for a 15-wk treatment period; Drug: Comparator: Placebo (unspecified); MK0557 Pbo tablet qd for a 15-wk treatment period
Other: 2 MK0557 Pbo tablet qd, crossing over to MK0557 10mg tablet qd.	Drug: MK0557; MK0557 10mg tablet qd for a 15-wk treatment period; Drug: Comparator: Placebo (unspecified); MK0557 Pbo tablet qd for a 15-wk treatment period

Outcome Measures

Primary Outcome Measures

1. 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]

Secondary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Merck Sharp & Dohme LLC

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT00482430
• Other Study ID Numbers: 0557-027; MK0557-027; 2007_520
• First Posted: Jun 5, 2007
• Last Update Posted: Aug 21, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by Merck Sharp & Dohme LLC: Undifferentiated schizophrenia; Residual schizophrenia
• Additional relevant MeSH terms: Schizophrenia; Cognitive Dysfunction; Schizophrenia, Paranoid

Study Results

No Results Posted as of Aug 21, 2015