Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy

Major Depression Clinical Trial

Official title:

Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy. A Double-blind, Placebo-controlled Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00595699
• Other study ID #: LXP-MD-116
• Secondary ID: LSUHSC IRB #6653
• Status: Completed
• Phase: Phase 4
• First received: January 3, 2008
• Last updated: July 14, 2011
• Start date: November 2006
• Est. completion date: December 2009

Study information

• Verified date: January 2008
• Source: Conrad, Erich J., M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Epilepsy
• Epilepsy, Temporal Lobe
• Major Depression
• Temporal Lobe Epilepsy

Intervention

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

Locations

Country	Name	City	State
United States	LSU Anxiety and Mood Disorders Clinic	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Conrad, Erich J., M.D.	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery And Asberg Depression Rating Scale		Screen, Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10	No
Secondary	Clinician's Global Impression Severity and Improvement subscales		Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10	No