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.

Study Overview

• Status: Completed
• Conditions: Major Depression; Temporal Lobe Epilepsy
• Intervention / Treatment: Drug: placebo; Drug: escitalopram

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • LSU Anxiety and Mood Disorders Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Double-blind	Drug: placebo; Placebo
Experimental: 1; escitalopram group	Drug: escitalopram; 10 mg daily for the first week followed by an increase to 20 mg daily for the remainder of the study; Other Names: Lexapro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Montgomery And Asberg Depression Rating Scale	Screen, Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinician's Global Impression Severity and Improvement subscales	Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10

Collaborators and Investigators

• Sponsor: Conrad, Erich J., M.D.
• Collaborators: Forest Laboratories
• Investigators: Principal Investigator: Erich J Conrad, M.D, LSUHSC

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: January 3, 2008
• First Submitted That Met QC Criteria: January 15, 2008
• First Posted (Estimate): January 16, 2008

Study Record Updates

• Last Update Posted (Estimate): July 18, 2011
• Last Update Submitted That Met QC Criteria: July 14, 2011
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Mood Disorders; Epilepsies, Partial; Epilepsy; Depression; Depressive Disorder; Depressive Disorder, Major; Epilepsy, Temporal Lobe; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: LXP-MD-116; LSUHSC IRB #6653