search
Back to results

Efficacy of Fluoxetine in Reducing Ictal Hypoventilation in Patients With Partial Epilepsy

Primary Purpose

Uncontrolled Partial Epilepsy, Ictal Hypoventilation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fluoxetine
Placebo
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Uncontrolled Partial Epilepsy focused on measuring fluoxetine, epilepsy, Prozac

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, Davis

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

fluoxetine

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 25, 2009
Last Updated
November 8, 2019
Sponsor
University of California, Davis
search

1. Study Identification

Unique Protocol Identification Number
NCT00986310
Brief Title
Efficacy of Fluoxetine in Reducing Ictal Hypoventilation in Patients With Partial Epilepsy
Official Title
Efficacy of Fluoxetine in Reducing Ictal Hypoventilation in Patients With Partial Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncontrolled Partial Epilepsy, Ictal Hypoventilation
Keywords
fluoxetine, epilepsy, Prozac

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fluoxetine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Other Intervention Name(s)
Prozac
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa M Bateman, MD, FRCPC
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Fluoxetine in Reducing Ictal Hypoventilation in Patients With Partial Epilepsy

We'll reach out to this number within 24 hrs