Lexapro for Major Depression in Patients With Epilepsy
The primary objective will be to pilot the use of escitalopram for the treatment of major depression in patients with epilepsy. The secondary objectives will be to determine effect sizes on scales measuring depressive symptoms, physical symptoms, psychosocial function and quality of life, and to evaluate safety in the population of patients with epilepsy.
These results will be used to evaluate the possibility of a future double-blind, placebo controlled RCT of escitalopram for the treatment of major depression in patients with epilepsy.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Lexapro for Major Depression in Patients With Epilepsy|
- Hamilton Depression Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
- National Hospital Seizure Severity Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2007|
|Study Completion Date:||March 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
escitalopram 10 mg or 20 mg/d
Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
Other Name: Escitalopram
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01244724
|United States, New York|
|Weill Medical College of Cornell University|
|New York, New York, United States, 10065|
|Principal Investigator:||James H Kocsis, MD||Weill Medical College of Cornell University|