Depression and Health Outcomes in Refractory Epilepsy

PHASE3CompletedINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

August 31, 2001

Primary Completion Date

June 30, 2007

Study Completion Date

June 30, 2008

Conditions
DepressionEpilepsy
Interventions
DRUG

sertraline

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.

BEHAVIORAL

cognitive behavior therapy

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.

Trial Locations (2)

10032

Columbia University Medical Center, New York

63110

Washington University School of Medicine, St Louis

All Listed Sponsors
collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

lead

Columbia University

OTHER

NCT00026637 - Depression and Health Outcomes in Refractory Epilepsy | Biotech Hunter | Biotech Hunter