To define the benefits of antidepressant treatment or cognitive behavior therapy on mood, function, and quality of life in patients with depression and refractory epilepsy.

Condition	Treatment or Intervention	Phase
Depression Epilepsy	Drug: sertraline  Behavior: cognitive behavior therapy	Phase III

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 patients with depression and a seizure disorder or epilepsy. Approximately 254 patients 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.

Ages Eligible for Study:  21 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

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).

Jewell Carter, R.N.      314-747-0558 
Tori Vahle, M.P.H.      314-362-7817 

Missouri
      Washington University School of Medicine, St. Louis,  Missouri,  United States; Recruiting

Study chairs or principal investigators

Frank Gilliam, M.D.,  Principal Investigator,  Dept. of Neurology, Columbia University, New York   

Study ID Numbers:  R01NS4080
Record last reviewed:  October 2004
Record first received:  November 14, 2001
ClinicalTrials.gov Identifier:  NCT00026637
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08