Back to resultsMK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0249-016)
Primary Purpose
Paranoid Schizophrenia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0249
Comparator: Placebo (unspecified)
Sponsored by
About this trial
This is an interventional treatment trial for Paranoid Schizophrenia focused on measuring Undifferentiated schizophrenia, residual 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MK0249
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.
The mean change from baseline after 4 weeks of treatment in total cognitive score on the BACS was calculated as a weighted average of T-scores (normalized for age) from BACS subtests including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Semantic Fluency, Letter Fluency, and Tower of London. The minimum and maximum values possible for this composite T-score of the change from baseline were -131 and 131, respectively. Higher values (positive changes from baseline) indicate better performance.
Secondary Outcome Measures
Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score
The Attention/Processing Speed Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological Battery (CNP) Penn Continuous Performance Test (PCPT) and BACS battery Symbol Coding. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -91 and 91, respectively. Higher values (positive changes from baseline) indicate better performance.
Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score
The Episodic Memory Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological Battery (CNP) Face Memory and BACS battery Verbal Memory. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -202 and 202, respectively. Higher values (positive changes from baseline) indicate better performance.
Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score
The Working Memory Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological (CNP) battery N-back test and the BACS battery Digit Sequencing test. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -122 and 122, respectively. Higher values (positive changes from baseline) indicate better performance.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00506077
Brief Title
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
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paranoid Schizophrenia
Keywords
Undifferentiated schizophrenia, residual schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MK0249
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MK0249
Intervention Description
MK0249 10mg (2 x 5 mg) tablet daily (qd) for 28 days.
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo (unspecified)
Intervention Description
MK0249 10mg (2 x 5 mg) Pbo tablet qd for a 28 day treatment period.
Primary Outcome Measure Information:
Title
Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.
Description
The mean change from baseline after 4 weeks of treatment in total cognitive score on the BACS was calculated as a weighted average of T-scores (normalized for age) from BACS subtests including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Semantic Fluency, Letter Fluency, and Tower of London. The minimum and maximum values possible for this composite T-score of the change from baseline were -131 and 131, respectively. Higher values (positive changes from baseline) indicate better performance.
Time Frame
Baseline and 4 weeks of treatment
Secondary Outcome Measure Information:
Title
Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score
Description
The Attention/Processing Speed Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological Battery (CNP) Penn Continuous Performance Test (PCPT) and BACS battery Symbol Coding. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -91 and 91, respectively. Higher values (positive changes from baseline) indicate better performance.
Time Frame
Baseline and 4 weeks of treatment
Title
Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score
Description
The Episodic Memory Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological Battery (CNP) Face Memory and BACS battery Verbal Memory. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -202 and 202, respectively. Higher values (positive changes from baseline) indicate better performance.
Time Frame
Baseline and 4 weeks of treatment
Title
Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score
Description
The Working Memory Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological (CNP) battery N-back test and the BACS battery Digit Sequencing test. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -122 and 122, respectively. Higher values (positive changes from baseline) indicate better performance.
Time Frame
Baseline and 4 weeks of treatment
Other Pre-specified Outcome Measures:
Title
Pre-randomization Baseline: Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.
Description
Pre-randomization baseline values for all treatment sequences are equal because
the constrained longitudinal data analysis (cLDA) model was used
(Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134-148).
Time Frame
Pre-randomization Baseline
Title
Pre-randomization Baseline: Attention/Processing Speed Composite Score
Description
Pre-randomization baseline values for all treatment sequences are equal because
the constrained longitudinal data analysis (cLDA) model was used
(Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134-148).
Time Frame
Pre-randomization Baseline
Title
Pre-randomization Baseline: Episodic Memory Composite Score
Description
Pre-randomization baseline values for all treatment sequences are equal because
the constrained longitudinal data analysis (cLDA) model was used
(Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134-148).
Time Frame
Pre-randomization Baseline
Title
Pre-randomization Baseline: Working Memory Composite Score
Description
Pre-randomization baseline values for all treatment sequences are equal because
the constrained longitudinal data analysis (cLDA) model was used
(Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134-148).
Time Frame
Pre-randomization Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
23523692
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.
Results Reference
derived
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MK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0249-016)
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