ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 289 for:    Fluoxetine
Previous Study | Return to List | Next Study

Efficacy of Fluoxetine Against Seizure-induced Central Apneas (FLUOXETINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02569970
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.


Condition or disease Intervention/treatment Phase
Epilepsy Ictal/Post-ictal Hypoxemia Drug: fluoxetine 20 mg Drug: placebo 20 mg Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Fluoxetine Against Seizure-induced Central Apneas : a Randomized Placebo-controled Double-blind Trial.
Study Start Date : November 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Fluoxetine

Arm Intervention/treatment
Active Comparator: FLUOXETINE
4 weeks of treatment before video-EEG monitoring
Drug: fluoxetine 20 mg

Fluoxetine 20 mg per day during 4 weeks prior to video-EEG, then continued during video-EEG.

At the end of video-EEG, and according to patient's decision, treatment was either progressively withdrawn (1 week at 10 mg per day and then 1 week at 5 mg per day), or replaced by fluoxetine 20 mg open-label.


Placebo Comparator: PLACEBO
1 month of treatment before EEG video.
Drug: placebo 20 mg

Placebo 20 mg per day during 4 weeks prior to video-EEG, then continued during video-EEG.

At the end of video-EEG, and according to patient's decision, treatment was either progressively withdrawn (1 week at 10 mg per day and then 1 week at 5 mg per day), or replaced by fluoxetine 20 mg open-label.





Primary Outcome Measures :
  1. Ictal/post-ictal hypoxemia [ Time Frame: Duration of video-EEG following 4 weeks of fluoxetine treatment ]
    Percentage of patients with at least one seizure associated with ictal/post-ictal SpO2 <90% in the group treated with fluoxetine compared to that receiving placebo.


Secondary Outcome Measures :
  1. Change in mood score with BDI-II score [ Time Frame: After four weeks of treatment as compared to baseline ]
    Changes in score of BDI-II after four weeks of treatment as compared to baseline in the group treated with fluoxetine compared to that receiving placebo

  2. Change in mood score with NDDIE score [ Time Frame: After four weeks of treatment as compared to baseline ]
    Changes in score of NDDIE after four weeks of treatment as compared to baseline in the group treated with fluoxetine compared to that receiving placebo

  3. Change in seizure frequency [ Time Frame: After four weeks of treatment as compared to baseline ]
    Changes in seizure frequency after four weeks of treatment as compared to baseline in the group treated with fluoxetine compared to that receiving placebo

  4. Change in sleep disorders score with SASDQ score [ Time Frame: After four weeks of treatment as compared to baseline ]
    Changes in score of SASDQ after four weeks of treatment as compared to baseline in the group treated with fluoxetine compared to that receiving placebo

  5. Change in sleep disorders score with EPWORTH score [ Time Frame: After four weeks of treatment as compared to baseline ]
    Changes in score of EPWORTH after four weeks of treatment as compared to baseline in the group treated with fluoxetine compared to that receiving placebo

  6. Change in score of quality of life [ Time Frame: After four weeks of treatment as compared to baseline ]
    Change in score of QOLIE-89 after four weeks of treatment as compared to baseline in the group treated with fluoxetine compared to that receiving placebo



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Acute heart disease
  • Antidepressant treatment
  • Other prohibited treatment (see detailed list in protocol).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569970


Locations
France
Service de Neurologie Fonctionnelle et d'Epileptologie, Hôpital Neurologique
Lyon, France
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Study Director: Philippe RYVLIN, Professor Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02569970     History of Changes
Other Study ID Numbers: 2009-562
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016

Keywords provided by Hospices Civils de Lyon:
Epilepsy
SUDEP
fluoxetine
placebo
SpO2

Additional relevant MeSH terms:
Fluoxetine
Epilepsy
Seizures
Hypoxia
Sleep Apnea, Central
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors