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Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy
This study is currently recruiting participants.
Study NCT00595699   Information provided by Conrad, Erich J., M.D.
First Received: January 3, 2008   Last Updated: January 27, 2009   History of Changes

January 3, 2008
January 27, 2009
November 2006
December 2009   (final data collection date for primary outcome measure)
Montgomery And Asberg Depression Rating Scale [ Time Frame: Screen, Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00595699 on ClinicalTrials.gov Archive Site
Clinician's Global Impression Severity and Improvement subscales [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10 ] [ Designated as safety issue: No ]
Same as current
 
Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy
Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy. A Double-Blind, Placebo-Controlled Study.

This is a research study evaluating the use of escitalopram (Lexapro®) for the treatment of major depression in subjects with temporal lobe epilepsy. The purpose of the study is to measure the severity and change in depressive and anxiety symptoms after 10 weeks of study treatment with escitalopram or placebo as measured by certain rating scales and questionnaires. In addition, the study will measure the frequency of seizures using a patient diary during the study. Finally, the study will assess the change in the quality of life using rating scales.

 
Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
  • Major Depression
  • Temporal Lobe Epilepsy
  • Drug: escitalopram
  • Drug: placebo
  • Placebo Comparator: Double-blind
  • Experimental: escitalopram group
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
24
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subject has a confirmed diagnosis of temporal lobe epilepsy
  2. Subject meets DSM-IV criteria for Major Depression
  3. MADRS greater than or equal to 15 at screening and baseline
  4. Subject between ages of 18 and 65
  5. Female subjects of childbearing potential must take adequate contraceptive precautions (methods with a published failure rate of less than 1% per year, or condom/diaphragm, or diaphragm/spermicide)
  6. Subject must provide voluntary signed informed consent approved by the Institutional Review Board of LSU Health Sciences Center

Exclusion Criteria:

  1. Any other primary axis I diagnosis other than Major Depression
  2. The presence of psychogenic, non-epileptic seizures
  3. A history of non-response to two or more antidepressants given for an adequate therapeutic trial
  4. The presence of substance abuse or dependence in past six months
  5. The presence of clinically significant malnutrition, cardiac, hepatic or renal disease that might endanger the safety of the subject
  6. Pregnancy or nursing
  7. Any subjects with suspected mental retardation, psychotic disorder or dementia
  8. Subjects whose anticonvulsant medication regimen includes phenobarbital
  9. Individuals who will require psychotropic medications such as benzodiazepines or medications likely to cause significant effects on mood or anxiety as outlined in section 5.4
  10. Cognitive-behavioral therapy will not be allowed during the course of the study. Other psychotherapeutic modalities (supportive, psychoanalytic, etc.) will be allowed only if the individual has been in therapy for the previous 12 weeks and plans to remain in therapy throughout the duration of the study.
  11. Individuals who in the opinion of the investigator would not be able to understand or comply with study requirements
  12. Individuals with a known hypersensitivity to escitalopram or any of its ingredients
  13. Individuals who in the opinion of the investigator present a significant risk of suicide, or have had a significant suicide attempt in the past two years.
Both
18 Years to 65 Years
No
Contact: Lisa S Gulledge, MS 504-412-1560 lgulle@lsuhsc.edu
United States
 
NCT00595699
Erich J. Conrad, M.D., LSUHSC
LXP-MD-116, LSUHSC IRB #6653
Conrad, Erich J., M.D.
Forest Laboratories
Principal Investigator: Erich J Conrad, M.D LSUHSC
Conrad, Erich J., M.D.
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP