Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
140 participants
INTERVENTIONAL
2001-08-31
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sertraline
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.
CBT
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
21 Years
75 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Columbia University
OTHER
Responsible Party
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Principal Investigators
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Frank Gilliam, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Countries
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References
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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.
Other Identifiers
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AAAB1084
Identifier Type: -
Identifier Source: org_study_id