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Lexapro for Major Depression in Patients With Epilepsy

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ClinicalTrials.gov Identifier: NCT01244724
Recruitment Status : Terminated (Unable to recruit targeted #)
First Posted : November 19, 2010
Results First Posted : August 3, 2015
Last Update Posted : July 11, 2018
Forest Laboratories
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:

The primary objective will be to pilot the use of escitalopram for the treatment of major depression in patients with epilepsy. The secondary objectives will be to determine effect sizes on scales measuring depressive symptoms, physical symptoms, psychosocial function and quality of life, and to evaluate safety in the population of patients with epilepsy.

These results will be used to evaluate the possibility of a future double-blind, placebo controlled RCT of escitalopram for the treatment of major depression in patients with epilepsy.

Condition or disease Intervention/treatment Phase
Major Depression Epilepsy Drug: Lexapro Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lexapro for Major Depression in Patients With Epilepsy
Study Start Date : October 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : March 2012

Arm Intervention/treatment
Experimental: Lexapro
escitalopram 10 mg or 20 mg/d
Drug: Lexapro
Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
Other Name: Escitalopram

Primary Outcome Measures :
  1. Hamilton Depression Scale [ Time Frame: 12 weeks ]
    Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)

Secondary Outcome Measures :
  1. National Hospital Seizure Severity Scale [ Time Frame: 12 Weeks ]
    Seizure severity score for each seizure type.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients will be 20 males or females above the age of 18 with a current major depressive episode, as defined by DSM-IV and assessed on the MINI, of at least 4 weeks duration.
  2. All subjects must have epilepsy, defined as the recurrence of seizures that are unprovoked and unpredictable, requiring treatment with an anti-epileptic medication under the care of a neurologist.
  3. Subjects must be stabilized on their antiepileptic drug (AED) regimen for the previous 2 months.
  4. If a vagus nerve stimulator is in place, the settings must be unchanged for the previous 2 months.
  5. Patients must be ages 18 - 75 and have a 24 item Hamilton Depression Rating Scale Score (HAM-D) at intake >/= 20.
  6. Subjects must be fluent in English and have the capacity to understand the nature of the study and sign the written informed consent.

Exclusion Criteria:

  1. Axis II diagnosis of antisocial, schizotypal or severe borderline personality disorder(defined as patients who are high risk for being unable to complete the study due to hospitalization, suicide attempts, significant self-mutilation, or other self-injurious or destructive behavior).
  2. History of psychosis, mania or hypomania.
  3. Subjects with more than 10 seizures per month that involve impairment of consciousness, such as complex partial or generalized seizures.
  4. Subjects unable to count seizures accurately, or do not have a someone in their home who can count seizures accurately .
  5. Unstable medical or neurological disorder (other than epilepsy).
  6. Epilepsies related to a progressive neurologic disease such as a brain tumor.
  7. Substance abuse including ETOH within the past 6 months.
  8. Need for concurrent psychotropic drugs with the exception of AEDs or zolpidem for sleep.
  9. Concurrent or recent (within 3 months) entry into a new psychotherapy.
  10. Actively or acutely suicidal.
  11. Failure to respond to escitalopram or to two or more other adequate antidepressant trials in the past year.
  12. Pregnancy or lactation.
  13. Females of child bearing potential who do not practice adequate contraception.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244724

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United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Forest Laboratories
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Principal Investigator: James H Kocsis, MD Weill Medical College of Cornell University
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01244724    
Other Study ID Numbers: LXP-MD-109
First Posted: November 19, 2010    Key Record Dates
Results First Posted: August 3, 2015
Last Update Posted: July 11, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs