Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy

• ClinicalTrials.gov Identifier: NCT00595699
• Recruitment Status: Completed
• First Posted: January 16, 2008
• Last Update Posted: July 18, 2011
• Sponsor: Conrad, Erich J., M.D.
• Collaborator: Forest Laboratories
• Information provided by: Conrad, Erich J., M.D.

Study Description

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

Study Design

• 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

Arms and Interventions

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 Name: Lexapro

Outcome Measures

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 ]

Eligibility Criteria

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

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.

Contacts and Locations

Locations

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

Investigators

• Principal Investigator: Erich J Conrad, M.D; LSUHSC

More Information

• Responsible Party: Erich J. Conrad, M.D., LSUHSC
• ClinicalTrials.gov Identifier: NCT00595699
• Other Study ID Numbers: LXP-MD-116; LSUHSC IRB #6653
• First Posted: January 16, 2008
• Last Update Posted: July 18, 2011
• Last Verified: January 2008

Additional relevant MeSH terms:

Epilepsy; Epilepsy, Temporal Lobe; Depression; Depressive Disorder; Depressive Disorder, Major; Behavioral Symptoms; Mood Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsies, Partial; Epileptic Syndromes; Citalopram; 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