Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy

Condition(s) targeted: Major Depression; Temporal Lobe Epilepsy

Intervention: escitalopram (Drug); placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Conrad, Erich J., M.D.

Official(s) and/or principal investigator(s):
Erich J Conrad, M.D, Principal Investigator, Affiliation: LSUHSC

Overall contact:
Lisa S Gulledge, MS, Phone: 504-412-1560, Email: lgulle@lsuhsc.edu

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.

Official title: Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy. A Double-Blind, Placebo-Controlled Study.

Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Montgomery And Asberg Depression Rating Scale

Secondary outcome: Clinician's Global Impression Severity and Improvement subscales

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Lisa S Gulledge, MS, Phone: 504-412-1560, Email: lgulle@lsuhsc.edu

LSU Anxiety and Mood Disorders Clinic, New Orleans, Louisiana 70115, United States; Recruiting
James G Barbee, M.D., Sub-Investigator

Starting date: November 2006
Last updated: January 27, 2009