Subjects randomized to treatment arm will receive fluoxetine with titration schedule consisting of 10 mg per day for 1 week, 20 mg per day for 1 week, 40 mg per day for 2 weeks, 20 mg per day for 1 week and 10 mg per day for 1 week. Then stop.

Subjects randomized to control arm will receive placebo with titration schedule consisting of 10 mg per day for 1 week, 20 mg per day for 1 week, 40 mg per day for 2 weeks, 20 mg per day for 1 week and 10 mg per day for 1 week. Then stop.

Subjects randomized to treatment arm will receive fluoxetine with titration schedule consisting of 10 mg per day for 1 week, 20 mg per day for 1 week, 40 mg per day for 2 weeks, 20 mg per day for 1 week and 10 mg per day for 1 week. Then stop.
Fluoxetine: Standard 6 weeks titration, starting 10 mg per day.

Treatment

Subjects randomized to control arm will receive placebo with titration schedule consisting of 10 mg per day for 1 week, 20 mg per day for 1 week, 40 mg per day for 2 weeks, 20 mg per day for 1 week and 10 mg per day for 1 week. Then stop.
Placebo: Standard 6 weeks titration.

Control

Total

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

Number of participants enrolled every 3 months.

Number of subjects (both fluoxetine and placebo arms) enrolled in the study.

Recruitment

Study Recruitment Rate

Number of participants completing the study every 3 months.

Subjects randomized to receive fluoxetine.

Fluoxetine

Placebo

Study Retention Rate

Minute ventilation was evaluated at baseline HCVR testing and HCVR testing at 4 weeks after receiving an intervention. Change from baseline was calculated.

Change in Minute Ventilation During Hypercapnic Ventilatory Response (HCVR) Testing

Patient Health Questionnaire (PHQ-9) was used to evaluate mood. Score on PHQ-9 scale ranges from 0-27. Scores corresponding to severity of depression: 0-4: minimal to none ; 5-9: mild; 10-14: moderate; 15-19 moderately severe; 20-27: severe. All subjects in the study were interviewed using standard questions per PHQ-09 questionnaire at baseline and 4 weeks after randomization to an intervention.

Change in PHQ-9 Score.

All the subjects undergo CO2 rebreathing (HCVR) testing at baseline and 4 weeks after receiving an intervention. During CO2 rebreathing (HCVR) testing, CO2 gradually rise in the body that stimulates breathing, which in turn increases minute ventilation (L/min). The rate of this increase in minute ventilation with each mm Hg rise in CO2 is the HCVR slope, which is calculated for baseline testing and 4 weeks after receiving an intervention. HCVR slope at 4 weeks after receiving an intervention compared to the baseline HCVR slope in each group.

Change in Slope of HCVR

Overall Study

Dr. Rup Sainju

Epilepsy

SUDEP

Standard 6 weeks titration, starting 10 mg per day.

The Univeristy of Iowa Hospitals and Clinics

Univeristy of Iowa Hospitals and Clinics

Abnormal Ventilatory Response to Carbon Dioxide: a Potential Biomarker for Seizure Induced Respiratory Depression & Modification by SSRI

Rup Kamal Sainju

Clinical Assistant Professor of Neurology

4 weeks of treatment before video-EEG monitoring

Ictal/Post-ictal Hypoxemia

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.

fluoxetine 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.

placebo 20 mg

Service de Neurologie Fonctionnelle et d'Epileptologie, Hôpital Neurologique

Efficacy of Fluoxetine Against Seizure-induced Central Apneas

Efficacy of Fluoxetine Against Seizure-induced Central Apneas : a Randomized Placebo-controled Double-blind Trial.

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.

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

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

Changes in seizure frequency after four weeks of treatment as compared to baseline in the group treated with fluoxetine compared to that receiving placebo

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

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

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

sudden unexpected death in epilepsy/セロトニン

Abnormal Ventilatory Response to Carbon Dioxide: a Potential Biomarker for Seizure Induced Respiratory Depression & Modification by SSRI

Efficacy of Fluoxetine Against Seizure-induced Central Apneas

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