Depression and Health Outcomes in Refractory Epilepsy

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Depression; Epilepsy	Drug: sertraline; Behavioral: cognitive behavior therapy	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	140 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Depression and Health Outcomes in Refractory Epilepsy
Study Start Date :	August 2001
Actual Primary Completion Date :	June 2007
Actual Study Completion Date :	June 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.
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 Name: CBT

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. MINI [ Time Frame: completed at screen and 16 weeks ]

Secondary Outcome Measures :

1. 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 ]
2. 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 ]
3. antiepileptic medication compliance [ Time Frame: assessed at 16 weeks ]
4. antiepileptic medication toxicity as measured by the AEP [ Time Frame: assessed every 2 weeks during the 16 week intervention period ]
5. seizure frequency and seizure severity [ Time Frame: assessed every 2 weeks during the 16 week intervention period ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	21 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Columbia University

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Principal Investigator:	Frank Gilliam, MD	Columbia University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Columbia University
ClinicalTrials.gov Identifier:	NCT00026637 History of Changes
Other Study ID Numbers:	AAAB1084; 5R01NS040808-04 ( U.S. NIH Grant/Contract )
First Posted:	November 15, 2001
Last Update Posted:	November 6, 2017
Last Verified:	November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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

Keywords provided by Columbia University:

depression; epilepsy; seizures

Additional relevant MeSH terms:

Depression; Depressive Disorder; Epilepsy; Drug Resistant Epilepsy; Behavioral Symptoms; Mood Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases	Sertraline; Antidepressive Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs