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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: | NCT00425815 |
The TURNS is a 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-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.
Condition | Intervention | Phase |
Schizophrenia |
Drug: Org 24448 (Ampakine) |
Phase II |
MedlinePlus related topics: | Schizophrenia |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Placebo-Controlled Trial of Org 24448 (Ampakine) Added to Atypical Antipsychotics in Patients With Schizophrenia |
Estimated Enrollment: | 135 |
Show Detailed Description |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Symptom Ratings:
Cognitive Status:
Performance less than the maximum cutoff (in parentheses) for ONE of the following MCCB tests:
Exclusion Criteria:
Concomitant medications are allowed except for:
A history of significant head injury/trauma, as defined by:
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, 02215 | |||||
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, 27710 |
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 |
Principal Investigator: | Don C Goff, MD | Harvard University |
Study ID Numbers: | TURNS01 |
First Received: | January 22, 2007 |
Last Updated: | July 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00425815 |
Health Authority: | United States: Food and Drug Administration |
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