Depression and Health Outcomes in Refractory Epilepsy

Phase 3

Completed

• Conditions: Depression; Epilepsy
• Interventions: Drug: sertraline; Behavioral: cognitive behavior therapy

• Registration Number: NCT00026637
• Lead Sponsor: Columbia University

Brief 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.

Detailed Description

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 Timeline

• Study Start: 2001-08
• Study First Submitted: 2001-11-14
• Study First Submitted QC: 2001-11-14
• Study First Posted: 2001-11-15
• Primary Completion: 2007-06
• Study Completion: 2008-06
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-02
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sertraline	sertraline	-
CBT	cognitive behavior therapy	-

Primary Outcome Measures

Name	Time	Method
MINI	completed at screen and 16 weeks

Secondary Outcome Measures

Name	Time	Method
Depression as measured by the CES-D	completed every 2 weeks during the 16 week intervention period and at 6 month and 1 year follow ups
antiepileptic medication toxicity as measured by the AEP	assessed every 2 weeks during the 16 week intervention period
seizure frequency and seizure severity	assessed every 2 weeks during the 16 week intervention period
Health Related Quality of life as measured by the QOILIE-89	completed every 4 weeks during the 16 week intervention period and at 6 month and 1 year follow ups
antiepileptic medication compliance	assessed at 16 weeks

Trial Locations

Locations (2)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States