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Depression and Health Outcomes in Refractory Epilepsy



Depression and Health Outcomes in Refractory Epilepsy

For Condition: Epilepsy,Depression
Status: Recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Randomized
Minimum Age/Maximum Age: 21 Years/75 Years
Genders: Both
Protocol Entry 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).
Total Enrollment: 254

Location and Contact Information:

Overall Study Official:
FrankGilliam,  Principal Investigator,  Washington University School of Medicine

Washington University School of Medicine *Recruiting*
St. Louis,  Missouri, 
United States
Recruiting Tori  Vahle 314-362-7845


Additional Information:
Study ID Numbers:  R01NS4080; 
Study Start Date: August 2001
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026637

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