Lexapro for Major Depression in Patients With Epilepsy

• Status: Terminated
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: Forest Laboratories
• Treatments: Citalopram; Dexetimide

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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