Lexapro for Major Depression in Patients With Epilepsy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01244724|
Recruitment Status : Terminated (Unable to recruit targeted #)
First Posted : November 19, 2010
Results First Posted : August 3, 2015
Last Update Posted : July 11, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Major Depression Epilepsy||Drug: Lexapro||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lexapro for Major Depression in Patients With Epilepsy|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||March 2012|
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
- Hamilton Depression Scale [ Time Frame: 12 weeks ]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 ]Seizure severity score for each seizure type.
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): 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|