Depression and Health Outcomes in Refractory Epilepsy

This study has been terminated.

(The PI left Columbia in 2008. No research related activity has taken place since then.)

Sponsor:

Collaborator:

National Institute of Neurological Disorders and Stroke (NINDS)

Information provided by (Responsible Party):

Columbia University

ClinicalTrials.gov Identifier:

NCT00026637

First received: November 14, 2001

Last updated: January 18, 2017

Last verified: January 2017

History of Changes

Purpose

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	Intervention	Phase
Depression Epilepsy	Drug: sertraline Behavioral: cognitive behavior therapy	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Depression and Health Outcomes in Refractory Epilepsy

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]


Enrollment:	140
Study Start Date:	August 2001
Study Completion Date:	June 2008
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00026637

Locations


United States, Missouri
Washington University School of Medicine
St. 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, M.D.	Dept. of Neurology, Columbia University, New York

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 )
Study First Received:	November 14, 2001
Last Updated:	January 18, 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

ClinicalTrials.gov processed this record on September 20, 2017

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