Clinical trial NCT00026637: Depression and Health Outcomes in Refractory Epilepsy
Official title: Depression and Health Outcomes in Refractory Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Epilepsy
Keywords: depression
epilepsy
seizures
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2001-11-15
Enrollment: 140
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: MINI
timeFrame: completed at screen and 16 weeks
Secondary outcomes:
measure: Depression as measured by the CES-D
timeFrame: completed every 2 weeks during the 16 week intervention period and at 6 month and 1 year follow ups
measure: Health Related Quality of life as measured by the QOILIE-89
timeFrame: completed every 4 weeks during the 16 week intervention period and at 6 month and 1 year follow ups
measure: antiepileptic medication compliance
timeFrame: assessed at 16 weeks
measure: antiepileptic medication toxicity as measured by the AEP
timeFrame: assessed every 2 weeks during the 16 week intervention period
measure: seizure frequency and seizure severity
timeFrame: assessed every 2 weeks during the 16 week intervention period
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Frank Gilliam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maguire MJ, Marson AG, Nevitt SJ. Antidepressants for people with epilepsy and depression. Cochrane Database Syst Rev. 2021 Apr 16;4(4):CD010682. doi: 10.1002/14651858.CD010682.pub3.