Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Lexapro for Major Depression in Patients With Epilepsy

This study has been terminated.
(Unable to recruit targeted #)
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01244724
First received: November 18, 2010
Last updated: July 29, 2015
Last verified: July 2015
Results First Received: December 24, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Major Depression
Epilepsy
Intervention: Drug: Lexapro

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 26 subjects enrolled only 17 actually returned and began medication.

Reporting Groups
  Description
Lexapro 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.

Participant Flow:   Overall Study
    Lexapro
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.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lexapro 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.

Baseline Measures
   Lexapro 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.9  (10.4) 
Gender 
[Units: Participants]
 
Female   10 
Male   5 
Region of Enrollment 
[Units: Participants]
 
United States   15 
Hamilton Depression Scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 25.5  (5.7) 
[1] total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)


  Outcome Measures

1.  Primary:   Hamilton Depression Scale   [ Time Frame: 12 weeks ]

2.  Secondary:   National Hospital Seizure Severity Scale   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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
e-mail: jhk2002@med.cornell.edu



Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01244724     History of Changes
Other Study ID Numbers: LXP-MD-109
Study First Received: November 18, 2010
Results First Received: December 24, 2014
Last Updated: July 29, 2015
Health Authority: United States: Food and Drug Administration