Org 24448 (Ampakine) for Cognitive Deficits in Schizophrenia
Status:
Withdrawn
Trial end date:
2009-04-01
Target enrollment:
Participant gender:
Summary
The TURNS is a National Institute of Mental Health (NIMH) funded contract for the evaluation
of new compounds for the treatment of cognitive impairments in schizophrenia (HHSN 27820044
1003C; P.I.: Steve Marder, M.D.). Despite advances in the safety, tolerability, and
effectiveness of antipsychotic medications for the treatment of schizophrenia, many patients
continue to be plagued by impairments in social and work functioning. Persons with
schizophrenia commonly show deficits in a number of areas of cognition that include
impairments in attention, memory, and executive functioning (the ability and organize one's
behavior). Importantly, a large body of literature now shows a link between cognition and
community functioning in schizophrenia. It is believed that treatments that improve cognitive
deficits may lead to improvements in work and social functioning.
A promising approach to improve the community functioning of patients with schizophrenia is
to develop new agents that treat the cognitive deficits of the illness. One type of
pharmacological compound that has shown promise at improving cognition is a group of drugs
called ampakines. These drugs are believed to improve the activity of a neurotransmitter
system in the brain called the glutamate system. Increased activity of this system has been
linked to improvements in cognitive functioning. The current study is an eight-week trial
comparing two doses of the ampakine drug, Org 24448, that will be added to patients' current
atypical antipsychotic medication. One hundred thirty-five patients with schizophrenia, drawn
from seven sites, will participate in the study. Cognition will be measured using a variety
of paper-and-pencil and computerized measures from the consensus-derived NIMH Measurement and
Treatment Research to Improve Cognition in Schizophrenia (MATRICS) cognitive battery.
Psychiatric symptoms and the ability to perform community-based tasks of daily living will
also be measured. Because previous trials with this drug and other similar drugs have
detected lasting cognitive benefits, this trial will also repeat clinical assessments four
weeks after completion of the study medication.
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