Depression and Health Outcomes in Refractory Epilepsy

Depression Clinical Trial

Official title:

Depression and Health Outcomes in Refractory Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00026637
• Other study ID #: AAAB1084
• Secondary ID: 5R01NS040808-04
• Status: Completed
• Phase: Phase 3
• First received: November 14, 2001
• Last updated: November 2, 2017
• Start date: August 2001
• Est. completion date: June 2008

Study information

• Verified date: November 2017
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Drug Resistant Epilepsy
• Epilepsy

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MINI		completed at screen and 16 weeks
Secondary	Depression as measured by the CES-D		completed every 2 weeks during the 16 week intervention period and at 6 month and 1 year follow ups
Secondary	Health Related Quality of life as measured by the QOILIE-89		completed every 4 weeks during the 16 week intervention period and at 6 month and 1 year follow ups
Secondary	antiepileptic medication compliance		assessed at 16 weeks
Secondary	antiepileptic medication toxicity as measured by the AEP		assessed every 2 weeks during the 16 week intervention period
Secondary	seizure frequency and seizure severity		assessed every 2 weeks during the 16 week intervention period