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

NCT00986310 | Completed Results

• 1 other identifier: 244486
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Uncontrolled Partial Epilepsy; Ictal Hypoventilation

Keywords

fluoxetine; epilepsy; Prozac

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (1)

• 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.

  6 weeks

Study Arms (2)

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.

Drug: Fluoxetine

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.

Drug: Placebo

Interventions

Fluoxetine DRUG

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.

Also known as: Prozac

fluoxetine

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Limitations and Caveats

PI has left institution. Despite many attempts to contact, no response was received and results were not able to obtained nor entered.

Results Point of Contact

• Title: Lisa Bateman, MD, FRCPC
• Organization: University of California, Davis

lb2863@cumc.columbia.edu

Study Officials

• Lisa M Bateman, MD, FRCPC

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2009
• First Posted: September 29, 2009
• Study Start: August 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 27, 2019
• Results First Posted: November 27, 2019

Record last verified: 2019-11

Locations

US (1)