- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00986310
Efficacy of Fluoxetine in Reducing Ictal Hypoventilation in Patients With Partial Epilepsy
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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California
-
Sacramento, California, United States, 95817
- University of California, Davis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult patients with temporal lobe epilepsy, aged 18-65.
- 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.
- Intelligence Quotient >70.
- Native English speaker or adequate fluency in English to provide informed consent.
- Female patients of child-bearing potential must be using an acceptable method of contraception, including abstinence.
Exclusion Criteria:
- Progressive neurological disease.
- Severe depression, bipolar disease or psychosis.
- History of suicidal ideation or intent.
- Clinically significant concurrent medical illness, including hepatic or renal insufficiency and diabetes.
- Pregnant or lactating women.
- Current heavy alcohol or illicit drug use.
- Patients already taking fluoxetine or other selective serotonin reuptake inhibitors (SSRIs).
- Concurrent use of monoaminoxidase inhibitors, antipsychotic agents, antidepressant agents other than SSRIs or frequent use of triptan agents.
- History of a previous allergic reaction or adverse effects with SSRIs.
- History of serotonin syndrome.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: fluoxetine
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.
|
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 Names:
|
Placebo Comparator: Placebo
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The Primary End Point for This Study is a 50% Fluoxetine-related Reduction in the Number of Seizures With Associated Oxygen Desaturations Below 90% Compared With Placebo.
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The Secondary End Point is, in the Group of Seizures With Desaturations Below 90%, a 30% Fluoxetine-related Improvement in the Oxygen Desaturation Nadir Relative to Placebo.
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lisa M Bateman, MD, FRCPC, University of California, Davis
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Signs and Symptoms, Respiratory
- Respiratory Insufficiency
- Epilepsy
- Epilepsies, Partial
- Hypoventilation
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Fluoxetine
Other Study ID Numbers
- 244486
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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