Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Conrad, Erich J., M.D.
ClinicalTrials.gov Identifier:
NCT00595699
First received: January 3, 2008
Last updated: July 14, 2011
Last verified: January 2008
  Purpose

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 Intervention Phase
Major Depression
Temporal Lobe Epilepsy
Drug: escitalopram
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy. A Double-blind, Placebo-controlled Study.

Resource links provided by NLM:


Further study details as provided by Conrad, Erich J., M.D.:

Primary Outcome Measures:
  • Montgomery And Asberg Depression Rating Scale [ Time Frame: Screen, Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinician's Global Impression Severity and Improvement subscales [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10 ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: November 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Lexapro

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595699

Locations
United States, Louisiana
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
  More Information

No publications provided

Responsible Party: Erich J. Conrad, M.D., LSUHSC
ClinicalTrials.gov Identifier: NCT00595699     History of Changes
Other Study ID Numbers: LXP-MD-116, LSUHSC IRB #6653
Study First Received: January 3, 2008
Last Updated: July 14, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Epilepsy
Depressive Disorder, Major
Epilepsy, Temporal Lobe
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsies, Partial
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014