Modafinil for Treatment of Cognitive Dysfunction in Schizophrenia

Completed · Phase 4 · Has a placebo group

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

Patients with schizophrenia have problems in thinking, known as cognitive dysfunction. This appears to be responsible for their difficulties in social and occupational functioning. One particular cognitive function that may be important for schizophrenia is called context processing. This refers to the ability to properly use information in the environment to guide thinking and behavior so that it is appropriate to the present circumstance. Problems with this function may explain why patients with schizophrenia think and act in unusual ways, and often have problems managing aspects of their lives that healthy adults take for granted. This cognitive function depends on a region of the brain called the prefrontal cortex, which shows impaired function in schizophrenia as well. Unfortunately, the biochemical aspects of this dysfunction are presently unknown, and it is not clear whether current psychiatric medications can improve this function. A recent FDA-approved medication that may improve this function is modafinil. Studies in animals and healthy adults show that this medication can improve cognitive functions which are related to context processing. We plan to study the effects of modafinil on context processing and the brain activity that underlies this function. We will use functional MRI and electrophysiology to examine the effects of modafinil, both after a single dose and after sustained (4 week) treatment. We predict that when patients receive modafinil they will perform better on cognitive tests and have improved activity in the regions of the brain that are responsible for these cognitive processes.

Key facts

Study ID

NCT00423943

Run by

University of California, Los Angeles

People needed

33

Starts

2005-09-01

Expected to finish

2012-12-01

Last updated by the study team

2017-09-29

Who can join

Age: 18 and older, up to 54. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• adults age 18-54
• diagnosis of schizophrenia or schizoaffective disorder, or healthy with no personal or family history of mental illness
• able to provide informed consent

You may not qualify if…

• history of significant head injury or other neurological illness
• active psychiatric illness requiring significant acute care
• significant intellectual impairment (e.g. standardized full-scale IQ < 70)
• history of medical illness or treatment that either interferes with experimental measures (e.g. cerebrovascular disease, anemias, etc.) or is associated with significant increase in risk from modafinil treatment (e.g. cardiac disease)
• significant active substance abuse
• presence of ferromagnetic foreign body or prosthesis
• active pregnancy
• active treatment with medications that have drug interactions with modafinil

Where it is running

• University of California Los Angeles School of Medicine — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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