Clinical trial NCT00595699: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depression
Temporal Lobe Epilepsy
Lead sponsor: Conrad, Erich J., M.D.
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2008-01-16
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Montgomery And Asberg Depression Rating Scale
timeFrame: Screen, Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10
Secondary outcomes:
measure: Clinician's Global Impression Severity and Improvement subscales
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: LSU Anxiety and Mood Disorders Clinic
state: Louisiana
Study officials:
affiliation: LSUHSC
name: Erich J Conrad, M.D
role: PRINCIPAL_INVESTIGATOR
References: