Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
University of California, Los Angeles University of Maryland Washington University School of Medicine Massachusetts General Hospital Nathan Kline Institute for Psychiatric Research Columbia University Duke University Beth Israel Deaconess Medical Center |
---|---|
Information provided by: | University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT00505076 |
Patients with schizophrenia are characterized by a broad range of neurocognitive abnormalities. These include impairments in attention, including abnormalities in sensory gating; executive function; visual and verbal learning and memory; working memory; processing speed; and social cognition (Nuechterlein et al, 2004). These impairments are major determinants of poor functional outcome in patients with schizophrenia (Green, 1996; Green et al, 2004). Conventional antipsychotics have limited effects on these impairments. Second generation antipsychotics may have modest benefits for cognitive function, but whether this represents a direct cognitive enhancing effect has not been established. Regardless, patients continue to exhibit pronounced cognitive impairments despite adequate second generation antipsychotic treatment. Adjunctive pharmacotherapy may offer a viable approach for the treatment of cognitive impairments. Adjunctive agents can be used to modulate specific neurotransmitter systems that are hypothesized to be involved in the pharmacology of cognitive functions.
The standard of care for schizophrenia is antipsychotic medications to treat psychotic symptoms. However, cognitive impairments remain and these impairments have been found to be significantly associated with the poor psychosocial function observed in patients with schizophrenia. There is a considerable preclinical rationale for the use of drugs that act at the GABAA α2 subunit as adjunctive treatments to target cognitive impairments.
MK-0777 provides an opportunity to directly test this mechanism.
The purpose of the proposed study is to examine the efficacy and safety of two doses of MK-0777 GEM, 3 mg BID and 8 mg BID, in the treatment of cognitive impairments in patients with schizophrenia. Secondary goals are to determine whether MK-0777 has beneficial effects on measures of functional capacity and patient self-report of cognitive function.
Condition | Intervention | Phase |
---|---|---|
Schizophrenia |
Drug: MK-0777 Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | MK-0777 for the Treatment of Cognitive Impairments in Patients With Schizophrenia |
Estimated Enrollment: | 90 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
MK-0777 GEM, 8 mg BID
|
Drug: MK-0777
MK-0777 GEM, 8 mg BID
|
2: Experimental
MK-0777 GEM, 3 mg BID
|
Drug: MK-0777
MK-0777 GEM, 3 mg BID
|
3: Placebo Comparator
2 tablets placebo BID
|
Drug: placebo
2 tablets placebo BID
|
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects will meet the following symptom criteria:
Subjects will meet the following cognitive performance criteria:
Exclusion Criteria:
Johns wort, kava-kava, Valerian, S-Adenosyl Methionine [SAMe])
Subjects with a history of significant head injury/trauma, as defined by one or more of the following:
United States, California | |
UCLA | |
Los Angeles, California, United States, 90073 | |
United States, Maryland | |
Maryland Psychiatric Research Center | |
Catonsville, Maryland, United States, 21228 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Harvard Medical School | |
Boston, Massachusetts, United States, 02115 | |
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 | |
United States, New York | |
Nathan Kline Institute | |
Orangeburg, New York, United States, 10962 | |
Columbia University Medical Center | |
New York, New York, United States, 10032 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27509 |
Principal Investigator: | Robert W Buchanan, M.D. | Maryland Psychiatric Research Center |
Responsible Party: | University of California, Los Angeles ( Stephen R. Marder, M.D. ) |
Study ID Numbers: | TURNS02, HHSN 278200441003C |
Study First Received: | July 19, 2007 |
Last Updated: | March 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00505076 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Cognition Schizophrenia |
Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Schizophrenia Mental Disorders Schizophrenia and Disorders with Psychotic Features |