Clinical trial NCT00506077: MK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0249-016)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Paranoid Schizophrenia
Keywords: Undifferentiated schizophrenia
residual schizophrenia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-07-25
Enrollment: 55
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and effectiveness of an investigational drug MK0249 for the treatment of the cognitive impairment in patients with schizophrenia.


Eligibility 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

Primary outcomes:
measure: Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.
timeFrame: Baseline and 4 weeks of treatment
Secondary outcomes:
measure: Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score
timeFrame: Baseline and 4 weeks of treatment
measure: Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score
timeFrame: Baseline and 4 weeks of treatment
measure: Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score
timeFrame: Baseline and 4 weeks of treatment
Other outcomes:
measure: Pre-randomization Baseline: Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.
timeFrame: Pre-randomization Baseline
measure: Pre-randomization Baseline: Attention/Processing Speed Composite Score
timeFrame: Pre-randomization Baseline
measure: Pre-randomization Baseline: Episodic Memory Composite Score
timeFrame: Pre-randomization Baseline
measure: Pre-randomization Baseline: Working Memory Composite Score
timeFrame: Pre-randomization Baseline
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: F Egan M, Zhao X, Gottwald R, Harper-Mozley L, Zhang Y, Snavely D, Lines C, Michelson D. Randomized crossover study of the histamine H3 inverse agonist MK-0249 for the treatment of cognitive impairment in patients with schizophrenia. Schizophr Res. 2013 May;146(1-3):224-30. doi: 10.1016/j.schres.2013.02.030. Epub 2013 Mar 22.