Depression and Health Outcomes in Refractory Epilepsy

This randomized clinical trial will be conducted to compare the drug sertraline to cognitive
behavioral therapy on symptoms of depression, antiepileptic medication compliance, seizure
frequency, and quality of life outcomes in persons with depression and a seizure disorder or
epilepsy. Approximately 140 persons will be enrolled in this study over a period of five
years. Individual participation will last approximately 16 weeks. Study participants will be
chosen randomly to receive either the study medication (sertraline) or cognitive behavior
therapy for 16 weeks. Sertraline is approved by the Food and Drug Administration (FDA).
Subjects who receive cognitive behavior therapy will be provided with a one-hour individual
session with a licensed clinical psychologist each week for 15 weeks. All study participants
will attend scheduled clinic visits every 4 weeks for 16 weeks.

INCLUSION:

- Must have a seizure disorder.

- Must meet the DSM-IV criteria for major depression.

- Must be willing to provide written informed consent.

- Must be age 21 to 75 years old.

- Must be compliant, cooperative, reliable, and able to follow instructions, and to
visit the clinic on schedule.

EXCLUSION:

- Have active suicidal or homicidal ideation.

- Have current alcohol or other substance abuse disorders or a history of bipolar
depression or any psychotic disorder.

- Are pregnant or lactating.

- Are known to be hypersensitive to sertraline.

- Have a progressive central nervous system disorder (such as a tumor or multiple
sclerosis), or severe hepatic or renal disease (serum creatinine >3 mg/dl).

- Currently taking an antidepressant medication or seeing a therapist regularly.