Back to resultsEscitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy
Primary Purpose
Major Depression, Temporal Lobe Epilepsy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
escitalopram
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depression
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- LSU Anxiety and Mood Disorders Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
2
1
Arm Description
Double-blind
escitalopram group
Outcomes
Primary Outcome Measures
Montgomery And Asberg Depression Rating Scale
Secondary Outcome Measures
Clinician's Global Impression Severity and Improvement subscales
Full Information
NCT ID
NCT00595699
First Posted
January 3, 2008
Last Updated
July 14, 2011
Sponsor
Conrad, Erich J., M.D.
Collaborators
Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT00595699
Brief Title
Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy
Official Title
Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy. A Double-blind, Placebo-controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Conrad, Erich J., M.D.
Collaborators
Forest Laboratories
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, Temporal Lobe Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Double-blind
Arm Title
1
Arm Type
Experimental
Arm Description
escitalopram group
Intervention Type
Drug
Intervention Name(s)
escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
10 mg daily for the first week followed by an increase to 20 mg daily for the remainder of the study
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Clinician's Global Impression Severity and Improvement subscales
Time Frame
Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erich J Conrad, M.D
Organizational Affiliation
LSUHSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
LSU Anxiety and Mood Disorders Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy
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