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| Sponsor: | University of California, Davis |
|---|---|
| Collaborator: |
Citizens United for Research in Epilepsy |
| Information provided by: | University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT00986310 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Uncontrolled Partial Epilepsy Ictal Hypoventilation |
Drug: Fluoxetine Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
| Official Title: | Efficacy of Fluoxetine in Reducing Ictal Hypoventilation in Patients With Partial Epilepsy |
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
fluoxetine: Active Comparator
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.
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Drug: Fluoxetine
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.
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Placebo: Placebo Comparator
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. 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.
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Drug: Placebo
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.
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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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Roxana Hupcey, CCRP | 916-734-6244 | roxana.hupcey@ucdmc.ucdavis.edu |
| United States, California | |
| University of California, Davis | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Roxana Hupcey, CCRP 916-734-6244 roxana.hupcey@ucdmc.ucdavis.edu | |
| Principal Investigator: Lisa M Bateman, MD, FRCPC | |
| Principal Investigator: | Lisa M Bateman, MD, FRCPC | University of California, Davis |
More Information
| Responsible Party: | University of California, Davis ( Lisa M. Bateman, MD, FRCPC ) |
| Study ID Numbers: | 200917358 |
| Study First Received: | September 25, 2009 |
| Last Updated: | September 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00986310 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
fluoxetine epilepsy Prozac |
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Epilepsies, Partial Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Respiration Disorders Psychotropic Drugs Hypoventilation Central Nervous System Diseases Brain Diseases Serotonin Uptake Inhibitors |
Pharmacologic Actions Fluoxetine Signs and Symptoms Serotonin Agents Respiratory Insufficiency Respiratory Tract Diseases Epilepsy Therapeutic Uses Signs and Symptoms, Respiratory Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |