Efficacy of Fluoxetine Against Seizure-induced Central Apneas (NCT02569970) | Clinical Trial Compass
CompletedPhase 3
Efficacy of Fluoxetine Against Seizure-induced Central Apneas
France70 participantsStarted 2010-11
Plain-language summary
Sudden unexpected death in epilepsy (SUDEP) is a tragic outcome of seizure disorders that primarily affect young adults suffering from refractory epilepsy. In this population, SUDEP incidence is estimated at 0.5%. While the mechanisms of SUDEP are not completely understood, it appears that the majority of such death occurs in the immediate aftermath of a general tonic-clonic seizure.
There is currently no validated preventive treatment for SUDEP. Some evidence suggest that modulation of the serotoninergic tone, and more specifically selective serotonin recapture inhibitor (SSRI) such as fluoxetine, might prevent SUDEP. Indeed, fluoxetine prevents seizure-induced lethal central apneas in DBA/2 and DBA/1 mice, one of the few animal models of SUDEP. Furthermore, serotoninergic bulbar nuclei are known to play a major role in the control of breathing, especially during sleep and in response to repeated hypoxia.
In patients with epilepsy undergoing in-hospital video-EEG monitoring, about one third of seizures are associated with decrease in SpO2 \<90%, an abnormality suspected to represent a risk factor of SUDEP. In a retrospective uncontrolled study, patients treated with SSRIs displayed less frequent ictal/post-ictal hypoxemia than patients not taking SSRIs.
The investigators project aimed at testing whether fluoxetine can reduce the risk of ictal/post-ictal hypoxemia by performing a double-blind, randomized, placebo-controlled trial in patients undergoing video-EEG monitoring as part of the pre-surgical evaluation of their focal drug-resistant epilepsy.
Who can participate
Age range
18 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:
Patient suffering from drug-resistant focal epilepsy
* Age ≥ 18 years
* Patient for whom a video-EEG monitoring of their seizures was scheduled as part of a pre-surgical assessment
* For women of childbearing age, a method of contraception considered effective by the investigator
* Patient who have given their written informed consent
* Patient accepting an interview with a psychologist and to be refered to a psychiatrist in the event that mood disorders were detected on mood scores and considered severe by the investigator and / or psychologist, leading to require psychiatric care or immediate antidepressant treatment
* Patient with a social security number
Exclusion Criteria:
* Age \< 18 years
* Patient under legal protection
* Pregnant or breastfeeding women
* Hypersensitivity to fluoxetine or its excipients
* History of other serious side effects related to an earlier prescription of fluoxetine;
* Current suicidal ideation or history of suicide attempt
* Manic episode
* Disruption of liver enzymes considered material by the investigator using the following criteria:
transaminases (ALT and AST)\> 2N alkaline phosphatase (ALP)\> 2N gamma glutamyl transpeptidase (GGT)\> 5N (performed as part of routine monitoring of epileptic patients on antiepileptic treatment. Patients often exhibit changed deemed clinically insignificant due to the enzyme-inducing effect of these drugs)
* Renal failure with creatinine clearance \<30 ml / min
* Acut…
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 tested fluoxetine — which is typically used as an antidepressant — to see if it could reduce dangerous drops in oxygen during or after seizures, so could you explain how fluoxetine might help with that specific problem in my situation?
2Since this was a Phase 3 trial and it has already been completed, has the data been published, and if so, did fluoxetine actually show a meaningful benefit in reducing seizure-related breathing problems or low oxygen levels?
3Given that this trial focused on ictal and post-ictal hypoxemia, how serious is that risk for me personally, and is it something my current epilepsy treatment plan is already addressing?
4If the results from this trial were promising, is fluoxetine something my care team would consider adding to my current treatment, and what side effects or interactions should I be aware of given my other medications?
5Are there other completed or ongoing studies looking at ways to reduce breathing complications during and after seizures that might also be worth discussing as alternatives to this approach?
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
Ictal/post-ictal hypoxemia
Timeframe: Duration of video-EEG following 4 weeks of fluoxetine treatment