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Depression and Health Outcomes in Refractory Epilepsy - Article


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Cognitive behavior therapy


Clinical Trial: Depression and Health Outcomes in Refractory Epilepsy

This study is currently recruiting patients.

Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

To define the benefits of antidepressant treatment or cognitive behavior therapy on mood, function, and quality of life in patients with depression and refractory epilepsy.

Condition Treatment or Intervention Phase
Depression
Epilepsy
 Drug: sertraline
 Behavior: cognitive behavior therapy
Phase III

MedlinePlus related topics:  Depression;   Epilepsy

Study Type: Interventional
Study Design: Randomized

Further Study Details: 

Expected Total Enrollment:  254

Study start: August 2001

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 patients with depression and a seizure disorder or epilepsy. Approximately 254 patients 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   -   75 Years,  Genders Eligible for Study:  Both

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).

Location and Contact Information

Tori Vahle, M.P.H.      314-362-7817 

Missouri
      Washington University School of Medicine, St. Louis,  Missouri,  United States; Recruiting
Tori Vahle, M.P.H.  314-362-7817 
Kevin Black, M.D.,  Principal Investigator

New York
      Columbia University Medical Center, New York,  New York,  United States; Recruiting
Alison Randall  212-305-1684 
Frank Gilliam, M.D., M.P.H.,  Principal Investigator

Study chairs or principal investigators

Frank Gilliam, M.D.,  Principal Investigator,  Dept. of Neurology, Columbia University, New York   

More Information

Study ID Numbers:  R01NS4080
Record last reviewed:  March 2005
Last Updated:  March 31, 2005
Record first received:  November 14, 2001
ClinicalTrials.gov Identifier:  NCT00026637
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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September 6, 2008



Page Updated: September 6, 2005
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