Ictal Hypoventilation Clinical Trial
Official title:
Efficacy of Fluoxetine in Reducing Ictal Hypoventilation in Patients With Partial Epilepsy
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.
Patients who consent to participate in the study will come to the clinic one week prior to
the scheduled date of hospitalization in the Epilepsy Monitoring Unit (EMU). At this visit a
complete physical examination including vital signs and complete neurological examination,
mental status, cranial nerves, motor examination, deep tendon reflexes, sensory examination,
coordinator and gait will be performed. Baseline laboratory studies including complete blood
count, serum electrolytes, renal and liver function studies and serum pregnancy test for
female patients will also be performed. Study medication will be dispensed at this visit.
Patients will be randomized to receive either 20 mg/day of fluoxetine (one pill) or placebo
(one pill), to be started one week prior to the scheduled hospital admission date. The dose
will be increased to two pills per day on day 1 of hospitalization bringing the total dose of
fluoxetine to 40 mg/day in patients randomized to receive this medication. On the day of
discharge from the hospital, the study medication will be reduced to 1 pill per day and the
patient will be instructed to stop the medication one week following discharge. A follow-up
clinic visit for the patient will be scheduled 1 month following hospital discharge, as is
the usual protocol for patients undergoing VET at our institution.
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