Depression and Health Outcomes in Refractory Epilepsy

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.

Study Overview

• Status: Completed
• Conditions: Depression; Epilepsy
• Intervention / Treatment: Drug: sertraline; Behavioral: cognitive behavior therapy

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 Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CBT	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.; Other Names: CBT
Active Comparator: Sertraline	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MINI	completed at screen and 16 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Frank Gilliam, MD, Columbia University

Publications and helpful links

General Publications

• Maguire MJ, Marson AG, Nevitt SJ. Antidepressants for people with epilepsy and depression. Cochrane Database Syst Rev. 2021 Apr 16;4(4):CD010682. doi: 10.1002/14651858.CD010682.pub3.

Study record dates

Study Major Dates

• Study Start: August 1, 2001
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: November 14, 2001
• First Submitted That Met QC Criteria: November 14, 2001
• First Posted (Estimate): November 15, 2001

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: depression; epilepsy; seizures
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mood Disorders; Epilepsy; Depression; Depressive Disorder; Drug Resistant Epilepsy; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Sertraline
• Other Study ID Numbers: AAAB1084; 5R01NS040808-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No