Treatment Study for Cognitive Deficits in Schizophrenia
Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
Participant gender:
Summary
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 Gamma-amino-buyric acid (GABA) α2 subunit as adjunctive treatments to target cognitive
impairments. MK-0777 GEM (Merck-0777 Gel Extrusion Module) formulation 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
(Merck) -0777 GEM, 3 mg BID (twice daily) and 8 mg BID (twice daily), 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.
Phase:
Phase 2
Details
Lead Sponsor:
University of California, Los Angeles
Collaborators:
Beth Israel Deaconess Medical Center Columbia University Duke University Massachusetts General Hospital Nathan Kline Institute for Psychiatric Research University of Maryland University of Maryland, College Park Washington University School of Medicine