Working… Menu

Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00595699
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : July 18, 2011
Forest Laboratories
Information provided by:
Conrad, Erich J., M.D.

Brief 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.

Condition or disease Intervention/treatment Phase
Major Depression Temporal Lobe Epilepsy Drug: escitalopram Drug: placebo Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy. A Double-blind, Placebo-controlled Study.
Study Start Date : November 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Placebo Comparator: 2
Drug: 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 Name: Lexapro

Primary Outcome Measures :
  1. Montgomery And Asberg Depression Rating Scale [ Time Frame: Screen, Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10 ]

Secondary Outcome Measures :
  1. Clinician's Global Impression Severity and Improvement subscales [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00595699

Layout table for location information
United States, Louisiana
LSU Anxiety and Mood Disorders Clinic
New Orleans, Louisiana, United States, 70115
Sponsors and Collaborators
Conrad, Erich J., M.D.
Forest Laboratories
Layout table for investigator information
Principal Investigator: Erich J Conrad, M.D LSUHSC
Layout table for additonal information
Responsible Party: Erich J. Conrad, M.D., LSUHSC Identifier: NCT00595699    
Other Study ID Numbers: LXP-MD-116
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: July 18, 2011
Last Verified: January 2008
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy, Temporal Lobe
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsies, Partial
Epileptic Syndromes
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs