Trial Outcomes & Findings for Efficacy of Fluoxetine in Reducing Ictal Hypoventilation in Patients With Partial Epilepsy (NCT NCT00986310)
NCT ID: NCT00986310
Last Updated: 2019-11-27
Results Overview
COMPLETED
NA
2 participants
6 weeks
2019-11-27
Participant Flow
The study was completed and the PI has left the institution without entering the results information. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Participant milestones
| Measure |
Fluoxetine
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.
Fluoxetine: 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.
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Placebo
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.
Placebo: 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.
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Overall Study
STARTED
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0
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0
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Overall Study
COMPLETED
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0
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0
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Fluoxetine in Reducing Ictal Hypoventilation in Patients With Partial Epilepsy
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 6 weeksPopulation: The study was completed and the PI has left the institution without entering the results information. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeksPopulation: The study was completed and the PI has left the institution without entering the results information. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Outcome measures
Outcome data not reported
Adverse Events
Fluoxetine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place