Lexapro for Major Depression in Patients With Epilepsy

Stopped early · Phase 4

Conditions studied: Major Depression, Epilepsy

In brief

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.

Key facts

Study ID

NCT01244724

Run by

Weill Medical College of Cornell University

People needed

26

Starts

2007-10-01

Expected to finish

2012-03-01

Last updated by the study team

2018-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• Subjects must be stabilized on their antiepileptic drug (AED) regimen for the previous 2 months.
• If a vagus nerve stimulator is in place, the settings must be unchanged for the previous 2 months.
• Patients must be ages 18 - 75 and have a 24 item Hamilton Depression Rating Scale Score (HAM-D) at intake >/= 20.
• Subjects must be fluent in English and have the capacity to understand the nature of the study and sign the written informed consent.

You may not qualify if…

• 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).
• History of psychosis, mania or hypomania.
• Subjects with more than 10 seizures per month that involve impairment of consciousness, such as complex partial or generalized seizures.
• Subjects unable to count seizures accurately, or do not have a someone in their home who can count seizures accurately .
• Unstable medical or neurological disorder (other than epilepsy).
• Epilepsies related to a progressive neurologic disease such as a brain tumor.
• Substance abuse including ETOH within the past 6 months.
• Need for concurrent psychotropic drugs with the exception of AEDs or zolpidem for sleep.
• Concurrent or recent (within 3 months) entry into a new psychotherapy.
• Actively or acutely suicidal.
• Failure to respond to escitalopram or to two or more other adequate antidepressant trials in the past year.
• Pregnancy or lactation.
• Females of child bearing potential who do not practice adequate contraception.

Where it is running

• Weill Medical College of Cornell University — New York, New York, United States

Full record on ClinicalTrials.gov

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