Efficacy of Fluoxetine in Reducing Ictal Hypoventilation in Patients With Partial Epilepsy

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effects of fluoxetine on breathing mechanisms during seizures. Patients with partial epilepsy commonly have changes in their breathing mechanisms during seizures. These changes may increase the risk of serious side effects from seizures, including sudden unexplained death in epilepsy (SUDEP), which affects 2-10 per 1000 patients with epilepsy each year. Fluoxetine (Prozac) may help to stimulate breathing through its actions in the brain and has been shown to improve breathing changes seen with seizures in certain animals. Fluoxetine is in a class of medications called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain, at synapses, the junctions at which nerve cells in the brain communicate. Fluoxetine is currently approved by the United States Food and Drug Administration (FDA) for the treatment of patients with Major Depressive Disorder, Obsessive Compulsive Disorder, Bulimia Nervosa, Panic Disorder and Premenstrual Dysphoric Disorder.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Davis
• Collaborator: Citizens United for Research in Epilepsy
• Treatments: Fluoxetine

Criteria

Inclusion Criteria:

1. Adult patients with temporal lobe epilepsy, aged 18-65.

2. Medical intractability of seizures such that VET to determine candidacy for epilepsy surgery is determined to be clinically appropriate for the patient by the primary treating epileptologist.

3. Intelligence Quotient >70.

4. Native English speaker or adequate fluency in English to provide informed consent.

5. Female patients of child-bearing potential must be using an acceptable method of contraception, including abstinence.

Exclusion Criteria:

1. Progressive neurological disease.

2. Severe depression, bipolar disease or psychosis.

3. History of suicidal ideation or intent.

4. Clinically significant concurrent medical illness, including hepatic or renal insufficiency and diabetes.

5. Pregnant or lactating women.

6. Current heavy alcohol or illicit drug use.

7. Patients already taking fluoxetine or other selective serotonin reuptake inhibitors (SSRIs).

8. Concurrent use of monoaminoxidase inhibitors, antipsychotic agents, antidepressant agents other than SSRIs or frequent use of triptan agents.

9. History of a previous allergic reaction or adverse effects with SSRIs.

10. History of serotonin syndrome.