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Trial record 1 of 1 for:    NCT00482430
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MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0557-027)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00482430
First Posted: June 5, 2007
Last Update Posted: August 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
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

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 ]

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00482430


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00482430     History of Changes
Other Study ID Numbers: 0557-027
MK0557-027
2007_520
First Submitted: May 31, 2007
First Posted: June 5, 2007
Last Update Posted: August 21, 2015
Last Verified: August 2015

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

Additional relevant MeSH terms:
Schizophrenia
Cognitive Dysfunction
Schizophrenia, Paranoid
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders