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Depression and Health Outcomes in Refractory Epilepsy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00026637
First Posted: November 15, 2001
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Columbia University
  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:


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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026637


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

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00026637     History of Changes
Other Study ID Numbers: AAAB1084
5R01NS040808-04 ( U.S. NIH Grant/Contract )
First Submitted: November 14, 2001
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