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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Sertraline: 25-200mg PO (orally); Subjects begin at 25mg for week 1 and increase to 50mg at the beginning of week 2. Sertraline is increased in 50mg increments when subjects score in the depressed range on the CES-D, a questionnaire that is administered every 2 weeks over the 16 week intervention period. Subjects may reduce dosage if toxicity occurs.
CBT (Cognitive Behavior Therapy) - CBT is a psychotherapy based on modifying cognitions, assumptions, beliefs and behaviors, with the aim of influencing disturbed emotions. Subjects will meet with a trained CBT therapist for 1 hour each week over the 16 week intervention period and will be given assignments to work on each week.
Washington University School of Medicine
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
MINI
Time frame: completed at screen and 16 weeks
Depression as measured by the CES-D
Time frame: completed every 2 weeks during the 16 week intervention period and at 6 month and 1 year follow ups
Health Related Quality of life as measured by the QOILIE-89
Time frame: completed every 4 weeks during the 16 week intervention period and at 6 month and 1 year follow ups
antiepileptic medication compliance
Time frame: assessed at 16 weeks
antiepileptic medication toxicity as measured by the AEP
Time frame: assessed every 2 weeks during the 16 week intervention period
seizure frequency and seizure severity
Time frame: assessed every 2 weeks during the 16 week intervention period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.