Modafinil for Treatment of Cognitive Dysfunction in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Cognitive Dysfunction; Psychotic Disorders
Intervention: modafinil; Placebos
Intervention description: 200 milligrams daily dose; capsule containing placebo
Intervention MeSH terms: Modafinil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 54 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cognition; memory

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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