Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: escitalopram
  • 10 mg daily for the first week followed by an increase to 20 mg daily for the remainder of the study
• Drug: placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 2
  • Double-blind
• Experimental: 1
  • escitalopram group

Primary Measures

• Montgomery And Asberg Depression Rating Scale
  • Time Frame: Screen, Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10
    Safety Issue?: No

Secondary Measures

• Clinician's Global Impression Severity and Improvement subscales
  • Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Conrad, Erich J., M.D.

Overall Clinical Trial Officials and Contacts

Erich J Conrad, M.D Principal Investigator LSUHSC  

Overall Contact: Lisa S Gulledge, MS 504-897-8559 lgulle@lsuhsc.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00595699

Study ID Number: LXP-MD-116

ClinicalTrials.gov Identifier: NCT00595699

Health Authority: United States: Institutional Review Board