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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00482430
First received: May 31, 2007
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Paranoid Schizophrenia
Schizophrenia
Drug: MK0557
Drug: Comparator: Placebo (unspecified)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Mean change from baseline at 4 weeks of treatment on a sequence of cognitive tests and that MK0557 generally well tolerated [ Time Frame: at 4 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change from baseline at 4 weeks of treatment on neuropsychological tests for executive functioning, episodic memory and working memory [ Time Frame: at 4 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: September 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482430

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00482430     History of Changes
Other Study ID Numbers: 0557-027, MK0557-027, 2007_520
Study First Received: May 31, 2007
Last Updated: September 3, 2014
Health Authority: Malaysia: Ministry of Health

Keywords provided by Merck Sharp & Dohme Corp.:
Undifferentiated schizophrenia
Residual schizophrenia

Additional relevant MeSH terms:
Cognition Disorders
Schizophrenia
Schizophrenia, Paranoid
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 25, 2014