Efficacy of Fluoxetine in Reducing Ictal Hypoventilation in Patients With Partial Epilepsy
Condition: Uncontrolled Partial Epilepsy; Ictal Hypoventilation
MeSH terms: Hypoventilation; Epilepsy; Epilepsies, Partial
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Fluoxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects randomized to fluoxetine will receive 20mg/day (one pill) for one week. The dose will be increased to 40mg/day (two pills) for the duration of hospitalization for VET. The dose will be decreased to 20 mg/day (one pill) from the day of hospital discharge for one week, at which time the medication will be discontinued.; Subjects randomized to fluoxetine will receive 20mg/day (one pill) for one week. The dose will be increased to 40mg/day (two pills) for the duration of hospitalization for VET. The dose will be decreased to 20 mg/day (one pill) from the day of hospital discharge for one week, at which time the medication will be discontinued.
Other intervention name(s): Prozac
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: fluoxetine; epilepsy; Prozac