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View Clinical Trial (Medical Research Study)
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Efficacy of Fluoxetine in Reducing Ictal Hypoventilation in Patients With Partial Epilepsy - NCT00986310-95817 (Clinical Trial 353046)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy353046.aspx
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| City: |
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Sacramento |
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State:
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CA |
| Zip Code: |
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95817 |
| Conditions: |
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Uncontrolled Partial Epilepsy - Ictal Hypoventilation |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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. |
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| Study is available at: |
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University of California, Davis
Sacramento, CA 95817
United States
Primary Contact:
Roxana Hupcey, CCRP
Email: roxana.hupcey@ucdmc.ucdavis.edu
Phone: 916-734-6244
Secondary Contact:
Roxana Hupcey, CCRP
Email: roxana.hupcey@ucdmc.ucdavis.edu
Phone: 916-734-6244 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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