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

NCT00482430 | Completed Phase 2

• 3 other identifiers: 0557-027MK0557-0272007_520
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Paranoid Schizophrenia; Schizophrenia

Keywords

Undifferentiated schizophrenia; Residual schizophrenia

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (2)

1

OTHER

MK0557 10mg tablet qd, crossing over to MK0557 Pbo tablet qd.

Drug: MK0557; Drug: Comparator: Placebo (unspecified)

2

OTHER

MK0557 Pbo tablet qd, crossing over to MK0557 10mg tablet qd.

Drug: MK0557; Drug: Comparator: Placebo (unspecified)

Interventions

MK0557 DRUG

MK0557 10mg tablet qd for a 15-wk treatment period

1; 2

Comparator: Placebo (unspecified) DRUG

MK0557 Pbo tablet qd for a 15-wk treatment period

1; 2

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Schizophrenia, Paranoid; Schizophrenia

Interventions

spiro(cyclohexane-1,3'(1'H)-furo(3,4-C)pyridine)-4-carboxamide, N-(1-(2-fluorophenyl)-1h-pyrazol-3-yl)-1'-oxo-, trans-

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2007
• First Posted: June 5, 2007
• Study Start: September 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: August 21, 2015

Record last verified: 2015-08