Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00595699
Other study ID # LXP-MD-116
Secondary ID LSUHSC IRB #6653
Status Completed
Phase Phase 4
First received January 3, 2008
Last updated July 14, 2011
Start date November 2006
Est. completion date December 2009

Study information

Verified date January 2008
Source Conrad, Erich J., M.D.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
escitalopram
10 mg daily for the first week followed by an increase to 20 mg daily for the remainder of the study
placebo
Placebo

Locations

Country Name City State
United States LSU Anxiety and Mood Disorders Clinic New Orleans Louisiana

Sponsors (2)

Lead Sponsor Collaborator
Conrad, Erich J., M.D. Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Montgomery And Asberg Depression Rating Scale Screen, Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10 No
Secondary Clinician's Global Impression Severity and Improvement subscales Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10 No
See also
  Status Clinical Trial Phase
Completed NCT03062150 - Mineralocorticoid Receptor, NMDA Receptor and Cognitive Function in Depression N/A
Completed NCT04352101 - Bupropion Versus Escitalopram on Reward Circuitry and Motivational Deficits Phase 4
Completed NCT02855918 - Blood Biomarkers in Suicidal Behaviour N/A
Recruiting NCT03039387 - Effects of tDCS on Cognitive Control and Emotion Regulation in Depressed Patients N/A
Recruiting NCT02213016 - Effectiveness of Repetitive Transcranial Magnetic Stimulation in Depressed Patients Phase 4
Completed NCT01683539 - Understanding How Cognitive Remediation Works N/A
Completed NCT01636791 - CBT Versus a Return to Work Intervention for Patients With Common Mental Illness in Primary Care Phase 3
Recruiting NCT02237937 - Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene Phase 4
Completed NCT01201148 - Open Pilot Trial of TES for Depression Phase 2
Completed NCT00953108 - Quetiapine Prolong, Escitalopram and Hypothalamic-pituitary-adrenocortical (HPA) Axis Activity in Depressed Patients Phase 3
Terminated NCT01244711 - Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines Phase 4
Completed NCT00711737 - Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months N/A
Terminated NCT00695552 - The Effect of Exercise on Depressive Symptoms in Unmedicated Patients N/A
Completed NCT00806143 - Bilateral Versus Monolateral Repetitive Transcranial Stimulation in Depression Phase 4
Completed NCT00466323 - The Effectiveness of FMPO in Improving the Quality of Care for Persons With Severe Mental Illness. N/A
Completed NCT00532480 - Study of Brain Response to Emotional Pictures Using a fMRI While on Duloxetine Phase 4
Completed NCT00482482 - Yoga in Unipolar and Bipolar Disorders N/A
Completed NCT00616759 - The Effect on Cognition of Terminating ECT Induced Seizures With Propofol N/A
Recruiting NCT00209807 - Effect of Escitalopram vs. Reboxetine on Gastro-intestinal Sensitivity of Patients With Major Depressive Disorder Phase 4
Completed NCT00149110 - Chronos: the Use of Chronobiological Treatment in Depression N/A