Abnormal Ventilatory Response to Carbon Dioxide: a Potential Biomarker for Seizure Induced Respir… (NCT02929667) | Clinical Trial Compass
CompletedPhase 2
Abnormal Ventilatory Response to Carbon Dioxide: a Potential Biomarker for Seizure Induced Respiratory Depression & Modification by SSRI
United States30 participantsStarted 2017-02-16
Plain-language summary
Sudden unexpected death in epilepsy patients (SUDEP) is devastating outcome for some patients with epilepsy. It ranks second only to stroke among neurological diseases in years of potential life lost. Patho-mechanisms of SUDEP remain not well understood, however peri-ictal respiratory dysfunction likely plays an important role in many cases.
Literature supports a critical role for the serotonergic system in central control of ventilation. Serotonin neurons in the raphe nuclei of the brainstem sense rising carbon dioxide and low pH, thereby stimulating breathing and arousal. These responses may serve as mechanisms that protect against asphyxia, particularly during sleep or the post-ictal state. In mouse models of seizure-induced sudden death, pre-treatment with selective serotonin reuptake inhibitor (SSRI) agents prevents death following seizures. Hence, the investigators hypothesize that a subset of drug resistant epilepsy patients who have impaired central chemo-responsiveness have a greater degree of peri-ictal respiratory depression, therefore a higher risk of SUDEP. The investigators further hypothesize that fluoxetine will improve central chemo-responsiveness and therefore will reduce peri-ictal respiratory depression.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult patients aged 18 or older
. Patients with epilepsy
. 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, and willing to refrain from sexual intercourse during the study.
Exclusion criteria
. Progressive neurological disease.
. Clinical diagnosis of bipolar disease, panic disorder, psychosis or severe depression, or PHQ-9 score \> 20
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial studied whether an abnormal breathing response to carbon dioxide might be a biomarker for seizure-related breathing problems — has my own breathing response to CO2 ever been evaluated, and is that something worth testing in my case?
2The trial also looked at whether SSRIs might modify seizure-induced respiratory depression — given that connection, is there any reason to discuss an SSRI as part of my epilepsy management, especially with SUDEP risk in mind?
3Since this was a Phase 2 study that has already been completed, has the data been published yet, and what did it find about whether this biomarker approach could actually help identify patients at higher risk for SUDEP?
4SUDEP is a serious concern for people with epilepsy — based on my specific seizure type and frequency, how worried should I be about my own risk, and are there monitoring or treatment strategies I should be considering right now?
5Since the trial measured recruitment and retention rates as its primary outcomes rather than clinical benefit, does that mean the main goal was to test whether this kind of study is even feasible, and are there follow-up trials I might be eligible for that go further?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Study Recruitment Rate
Timeframe: From the date of enrollment every 3 months up to 2 years
2
Study Retention Rate
Timeframe: From date of enrollment until either completion of study or lost to follow up every 3 months up to 2 years and 3 months
. Patients with prior hospitalization related to depression or Electroconvulsive therapy.
. History of suicidal ideation or intent in past or present
. Clinical history or laboratory evidence of hepatic or renal insufficiency.
. Pregnant or lactating women.
. Current heavy alcohol use (\>14 drinks per week for men or \>7 drinks per week for women) or) known medical disorder related to alcohol use or current illicit drug use, other than marijuana and its derivatives.
. Patients with recent use (\<1 month) or already taking fluoxetine or other selective serotonin reuptake inhibitors (SSRIs).