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Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy

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

Tracking Information
First Submitted Date  ICMJE January 3, 2008
First Posted Date  ICMJE January 16, 2008
Last Update Posted Date July 18, 2011
Study Start Date  ICMJE November 2006
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2008)
Montgomery And Asberg Depression Rating Scale [ Time Frame: Screen, Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00595699 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2008)
Clinician's Global Impression Severity and Improvement subscales [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy
Official Title  ICMJE Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy. A Double-blind, Placebo-controlled Study.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depression
  • Temporal Lobe Epilepsy
Intervention  ICMJE
  • 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
  • Drug: placebo
    Placebo
Study Arms  ICMJE
  • Placebo Comparator: 2
    Double-blind
    Intervention: Drug: placebo
  • Experimental: 1
    escitalopram group
    Intervention: Drug: escitalopram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2011)
8
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2008)
24
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00595699
Other Study ID Numbers  ICMJE LXP-MD-116
LSUHSC IRB #6653
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erich J. Conrad, M.D., LSUHSC
Study Sponsor  ICMJE Conrad, Erich J., M.D.
Collaborators  ICMJE Forest Laboratories
Investigators  ICMJE
Principal Investigator: Erich J Conrad, M.D LSUHSC
PRS Account Conrad, Erich J., M.D.
Verification Date January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP