Lexapro for Major Depression in Patients With Epilepsy
Condition: Major Depression; Epilepsy
MeSH terms: Epilepsy; Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Lexapro
Intervention description: 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.
Intervention MeSH terms: Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.

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