Depression and Health Outcomes in Refractory Epilepsy

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Sertraline

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).

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