Org 24448 (Ampakine) for Cognitive Deficits in Schizophrenia

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.

Conditions

• Schizophrenia

Interventions

DRUG

Org 24448

Org 24448 is a moderate-potency selective AMPA positive modulator that enhances the glutamate system in the brain.

OTHER

Placebo

Placebo comparison

Sponsors & Collaborators

• University of Maryland

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Nathan Kline Institute for Psychiatric Research

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Duke University

  collaborator OTHER

• Beth Israel Deaconess Medical Center

  collaborator OTHER

• University of California, Los Angeles

  lead OTHER

Principal Investigators

• Don C Goff, MD · Harvard University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-04-30

Primary Completion

2009-04-30

Completion

2009-04-30

Countries

• United States

Study Locations