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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 12, 2012
Last verified: January 2012
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: Open Label
Primary Purpose: Treatment
Official Title: Depression and Health Outcomes in Refractory Epilepsy

Resource links provided by NLM:

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
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
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
ClinicalTrials.gov Identifier: NCT00026637     History of Changes
Other Study ID Numbers: AAAB1084, R01NS4080
Study First Received: November 14, 2001
Last Updated: January 12, 2012
Health Authority: United States: Federal Government

Keywords provided by Columbia University:
depression
epilepsy
seizures

Additional relevant MeSH terms:
Depression
Depressive Disorder
Epilepsy
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sertraline
Antidepressive Agents
 Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013