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

August 20, 2015 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at 4 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
at 4 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

May 31, 2007

First Submitted That Met QC Criteria

June 1, 2007

First Posted (Estimate)

June 5, 2007

Study Record Updates

Last Update Posted (Estimate)

August 21, 2015

Last Update Submitted That Met QC Criteria

August 20, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0557-027
  • MK0557-027
  • 2007_520

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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