Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy

NCT00595699 | Completed Phase 4

• 2 other identifiers: LXP-MD-116LSUHSC IRB #6653
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression; Temporal Lobe Epilepsy

Outcome Measures

Primary Outcomes (1)

• Montgomery And Asberg Depression Rating Scale

  Screen, Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10

Secondary Outcomes (1)

• Clinician's Global Impression Severity and Improvement subscales

  Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10

Study Arms (2)

2

PLACEBO COMPARATOR

Double-blind

Drug: placebo

1

EXPERIMENTAL

escitalopram group

Drug: escitalopram

Interventions

escitalopram DRUG

10 mg daily for the first week followed by an increase to 20 mg daily for the remainder of the study

Also known as: Lexapro

1

placebo DRUG

Placebo

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has a confirmed diagnosis of temporal lobe epilepsy
• Subject meets DSM-IV criteria for Major Depression
• MADRS greater than or equal to 15 at screening and baseline
• Subject between ages of 18 and 65
• 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)
• Subject must provide voluntary signed informed consent approved by the Institutional Review Board of LSU Health Sciences Center

You may not qualify if:

• Any other primary axis I diagnosis other than Major Depression
• The presence of psychogenic, non-epileptic seizures
• A history of non-response to two or more antidepressants given for an adequate therapeutic trial
• The presence of substance abuse or dependence in past six months
• The presence of clinically significant malnutrition, cardiac, hepatic or renal disease that might endanger the safety of the subject
• Pregnancy or nursing
• Any subjects with suspected mental retardation, psychotic disorder or dementia
• Subjects whose anticonvulsant medication regimen includes phenobarbital
• 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
• 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.
• Individuals who in the opinion of the investigator would not be able to understand or comply with study requirements
• Individuals with a known hypersensitivity to escitalopram or any of its ingredients
• 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.

Sponsors & Collaborators

• Conrad, Erich J., M.D.: lead
• Forest Laboratories: collaborator

Study Sites (1)

LSU Anxiety and Mood Disorders Clinic

New Orleans, Louisiana, 70115, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Epilepsy, Temporal Lobe

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Erich J Conrad, M.D

  LSUHSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 3, 2008
• First Posted: January 16, 2008
• Study Start: November 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 18, 2011

Record last verified: 2008-01

Locations

US (1)