Depression and Health Outcomes in Refractory Epilepsy
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ClinicalTrials.gov Identifier: NCT00026637 |
Recruitment Status
:
Completed
First Posted
: November 15, 2001
Last Update Posted
: November 6, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Depression Epilepsy | Drug: sertraline Behavioral: cognitive behavior therapy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 140 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Depression and Health Outcomes in Refractory Epilepsy |
Study Start Date : | August 2001 |
Actual Primary Completion Date : | June 2007 |
Actual Study Completion Date : | June 2008 |

Arm | Intervention/treatment |
---|---|
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.
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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
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- MINI [ Time Frame: completed at screen and 16 weeks ]
- 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 ]

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Ages Eligible for Study: | 21 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
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 |
Principal Investigator: | Frank Gilliam, MD | Columbia University |
Responsible Party: | Columbia University |
ClinicalTrials.gov Identifier: | NCT00026637 History of Changes |
Other Study ID Numbers: |
AAAB1084 5R01NS040808-04 ( U.S. NIH Grant/Contract ) |
First Posted: | November 15, 2001 Key Record Dates |
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 |