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Lexapro for Major Depression in Patients With Epilepsy

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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
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Major Depression
Epilepsy
Intervention Drug: Lexapro
Enrollment 26
Recruitment Details  
Pre-assignment Details Of the 26 subjects enrolled only 17 actually returned and began medication.
Arm/Group Title Lexapro
Hide Arm/Group Description Lexapro: 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.
Period Title: Overall Study
Started 17 [1]
Week 2 Visit 15
Completed 9
Not Completed 8
[1]
Of these 15 returned for a week 2 visit and are included in the efficacy analysis.
Arm/Group Title Lexapro
Hide Arm/Group Description Lexapro: 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.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
39.9  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
10
  66.7%
Male
5
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
Hamilton Depression Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants
25.5  (5.7)
[1]
Measure Description: total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
1.Primary Outcome
Title Hamilton Depression Scale
Hide Description Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lexapro
Hide Arm/Group Description:
Lexapro: 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.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.3  (9.7)
2.Secondary Outcome
Title National Hospital Seizure Severity Scale
Hide Description Seizure severity score for each seizure type.
Time Frame 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of this study, data were not collected.
Arm/Group Title Lexapro
Hide Arm/Group Description:
Lexapro: 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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Twelve weeks.
Adverse Event Reporting Description Adverse events were identified though standardized questionnaire administered by the research team and reviewed by the Principal Investigator.
 
Arm/Group Title Lexapro
Hide Arm/Group Description Lexapro: 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.
All-Cause Mortality
Lexapro
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lexapro
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lexapro
Affected / at Risk (%) # Events
Total   4/15 (26.67%)    
Nervous system disorders   
headache   4/15 (26.67%)  4
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: James H. Kocsis, M.D.
Organization: Weill Cornell Medical College
Phone: 212-746-5913
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01244724     History of Changes
Other Study ID Numbers: LXP-MD-109
First Submitted: November 18, 2010
First Posted: November 19, 2010
Results First Submitted: December 24, 2014
Results First Posted: August 3, 2015
Last Update Posted: July 11, 2018