Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy

Sponsor
Conrad, Erich J., M.D. (Other)
Overall Status
Completed
CT.gov ID
NCT00595699
Collaborator
Forest Laboratories (Industry)
8
1
2
37
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Study Details

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
Phase 4

Study Design

Study Type:
Interventional
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 :
Nov 1, 2006
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 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 Names:
  • Lexapro
  • Outcome Measures

    Primary Outcome Measures

    1. Montgomery And Asberg Depression Rating Scale [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 [Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00595699
    Other Study ID Numbers:
    • LXP-MD-116
    • LSUHSC IRB #6653
    First Posted:
    Jan 16, 2008
    Last Update Posted:
    Jul 18, 2011
    Last Verified:
    Jan 1, 2008

    Study Results

    No Results Posted as of Jul 18, 2011