Depression and Health Outcomes in Refractory Epilepsy - Full Text View

Sponsor:	Columbia University
Collaborator:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00026637

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Depression and Health Outcomes in Refractory Epilepsy

Resource links provided by NLM:

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

MedlinePlus related topics: Depression Epilepsy Seizures

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

MINI [ Time Frame: completed at screen and 16 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
antiepileptic medication compliance [ Time Frame: assessed at 16 weeks ] [ Designated as safety issue: No ]
antiepileptic medication toxicity as measured by the AEP [ Time Frame: assessed every 2 weeks during the 16 week intervention period ] [ Designated as safety issue: No ]
seizure frequency and seizure severity [ Time Frame: assessed every 2 weeks during the 16 week intervention period ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
Sertraline: Active Comparator	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.
CBT: Active Comparator	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.

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
Genders Eligible for Study:	Both
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

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
United States, New York
Columbia University Medical Center
New York, New York, United States

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

No publications provided

Responsible Party:	Columbia University, Dept. of Neurology, New York ( Frank Gilliam, M.D. )
Study ID Numbers:	R01NS4080
Study First Received:	November 14, 2001
Last Updated:	May 27, 2009
ClinicalTrials.gov Identifier:	NCT00026637 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Columbia University:

depression
epilepsy
seizures

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Psychotropic Drugs
Central Nervous System Diseases
Depressive Disorder
Brain Diseases
Serotonin Uptake Inhibitors

Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Epilepsy
Mental Disorders
Therapeutic Uses
Mood Disorders
Sertraline
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 27, 2009