MK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0249-016)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00506077
• Date of registration: 24/07/2007
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp.
• Public title: MK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0249-016)
• Scientific title: A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, 2-Period, Cross-Over Clinical Trial to Study the Safety and Efficacy of MK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia
• Date of first enrolment: December 2007
• Target sample size: 55
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00506077
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

India, Russian Federation

Contacts

• Name: Medical Monitor
• Affiliation: Merck Sharp & Dohme Corp.

Key inclusion & exclusion 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

- Females are not pregnant, and those who can have children agree to remain abstinent or
use acceptable birth control throughout the 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

- Patient has total Positive and Negative Syndrome Scale (PANSS) score between 36 and 75
at screening and at the first baseline visit

- Patient has a Clinical Global Impressions - Severity (CGI-S) score less than or equal
to 4 at screening and at the first baseline visit

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 or clozapine 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 the past 5 years

- Patient has a history of alcohol or drug dependence within the past year or alcohol or
drug abuse within 3 months of screening



Age minimum: 21 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Paranoid Schizophrenia

Intervention(s)

Drug: MK0249

Drug: Comparator: Placebo (unspecified)

Primary Outcome(s)

Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery. [Time Frame: Baseline and 4 weeks of treatment]

Secondary Outcome(s)

Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score [Time Frame: Baseline and 4 weeks of treatment]

Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score [Time Frame: Baseline and 4 weeks of treatment]

Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score [Time Frame: Baseline and 4 weeks of treatment]

Secondary ID(s)

0249-016

2007_522

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/03/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00506077