Trial Outcomes & Findings for Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension (NCT NCT00942708)
NCT ID: NCT00942708
Last Updated: 2020-06-02
Results Overview
PVR will be measured by right heart catheterization at baseline and 3 months. Change in PVR will be determined by baseline value minus 3 month value.
COMPLETED
PHASE2
6 participants
Change in PVR at 3 mos (Baseline - 3 months)
2020-06-02
Participant Flow
Participant milestones
| Measure |
Fluoxetine
In this single arm study, participants begin fluoxetine at 20 mg daily. If tolerated, the dose is increased every 2 weeks as follows:
Starting dose: 20 mg daily (week 1-2) Next dose: 40 mg daily (week 3-4) Next dose: 40 mg twice daily (week 5-12)
If unable to tolerate uptitration, participants may remain at a lower dose.
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|---|---|
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Overall Study
STARTED
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6
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Overall Study
COMPLETED
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5
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Fluoxetine
In this single arm study, participants begin fluoxetine at 20 mg daily. If tolerated, the dose is increased every 2 weeks as follows:
Starting dose: 20 mg daily (week 1-2) Next dose: 40 mg daily (week 3-4) Next dose: 40 mg twice daily (week 5-12)
If unable to tolerate uptitration, participants may remain at a lower dose.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension
Baseline characteristics by cohort
| Measure |
Fluoxetine
n=6 Participants
Fluoxetine will be added starting at 20 mg and titrated as tolerated to 80 mg daily.
Fluoxetine: :
Week 1-2 20 mg daily Week 3-4 40 mg daily Week 5-12 40 mg BID
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|---|---|
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Age, Continuous
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48.2 years
STANDARD_DEVIATION 11.2 • n=93 Participants
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Sex: Female, Male
Female
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5 Participants
n=93 Participants
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Sex: Female, Male
Male
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1 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: Change in PVR at 3 mos (Baseline - 3 months)PVR will be measured by right heart catheterization at baseline and 3 months. Change in PVR will be determined by baseline value minus 3 month value.
Outcome measures
| Measure |
Fluoxetine
n=5 Participants
Fluoxetine will be started at 20 mg and increased every 2 weeks as tolerated to 80 mg daily.
Week 1-2 20 mg daily Week 3-4 40 mg daily Week 5-12 40 mg twice daily
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|---|---|
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Change in Pulmonary Vascular Resistance (PVR) at Three Months
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-0.49 Wood units
Standard Deviation 0.49
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SECONDARY outcome
Timeframe: Baseline - 3 months (median change)The Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR) depression scale is a questionnaire completed by the patient. Lower scores are better. Scoring can be interpreted as 7 or less: normal, 8-12: mild depression, 13-16 moderate depression, 17-20 moderate to severe depression and \>20 severe depression. Results here show the median change between baseline and 3 months, making a positive change in score indicative of improvement. Total minimum score is 0 and the maximum is 27.
Outcome measures
| Measure |
Fluoxetine
n=5 Participants
Fluoxetine will be started at 20 mg and increased every 2 weeks as tolerated to 80 mg daily.
Week 1-2 20 mg daily Week 3-4 40 mg daily Week 5-12 40 mg twice daily
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|---|---|
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Change Between Baseline and Three Month in the QIDS-SR Depression Scale
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1 units on a scale
Interval -1.0 to 10.0
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SECONDARY outcome
Timeframe: 3 monthsPopulation: All patients completing the 12 week study were analyzed
Six minute walk distance will be measured at baseline and after 3 months of fluoxetine. Change in walk distance (mean and SD) will be reported by taking subtracting baseline values from result at 3 months.
Outcome measures
| Measure |
Fluoxetine
n=5 Participants
Fluoxetine will be started at 20 mg and increased every 2 weeks as tolerated to 80 mg daily.
Week 1-2 20 mg daily Week 3-4 40 mg daily Week 5-12 40 mg twice daily
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|---|---|
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Change in Six Minute Walk Distance at 3 Months
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10 meters
Standard Deviation 48
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Adverse Events
Fluoxetine
Serious adverse events
| Measure |
Fluoxetine
n=6 participants at risk
Fluoxetine will be added starting at 20 mg and titrated as tolerated to 80 mg daily.
Fluoxetine:
Week 1-2 20 mg daily Week 3-4 40 mg daily Week 5-12 40mg BID
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|---|---|
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Cardiac disorders
Chest pain or tightness
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16.7%
1/6 • Number of events 1 • 12 weeks
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Product Issues
Line malfunction
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16.7%
1/6 • Number of events 6 • 12 weeks
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Other adverse events
| Measure |
Fluoxetine
n=6 participants at risk
Fluoxetine will be added starting at 20 mg and titrated as tolerated to 80 mg daily.
Fluoxetine:
Week 1-2 20 mg daily Week 3-4 40 mg daily Week 5-12 40mg BID
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|---|---|
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Infections and infestations
Cold
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16.7%
1/6 • Number of events 1 • 12 weeks
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Cardiac disorders
Syncope
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16.7%
1/6 • Number of events 1 • 12 weeks
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Gastrointestinal disorders
Nausea
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33.3%
2/6 • Number of events 2 • 12 weeks
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Gastrointestinal disorders
Heartburn
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16.7%
1/6 • Number of events 1 • 12 weeks
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Nervous system disorders
Drowsiness
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16.7%
1/6 • Number of events 1 • 12 weeks
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Psychiatric disorders
Nervousness
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16.7%
1/6 • Number of events 1 • 12 weeks
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Gastrointestinal disorders
Diarrhea
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16.7%
1/6 • Number of events 1 • 12 weeks
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Cardiac disorders
Lightheadedness
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16.7%
1/6 • Number of events 1 • 12 weeks
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Nervous system disorders
Shaking
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16.7%
1/6 • Number of events 1 • 12 weeks
|
|
Nervous system disorders
Yawning
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16.7%
1/6 • Number of events 1 • 12 weeks
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|
Psychiatric disorders
Anxiety
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16.7%
1/6 • Number of events 1 • 12 weeks
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Nervous system disorders
Lack of concentration
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16.7%
1/6 • Number of events 1 • 12 weeks
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Cardiac disorders
Chest pain
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16.7%
1/6 • Number of events 1 • 12 weeks
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Respiratory, thoracic and mediastinal disorders
Shortness of breath
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16.7%
1/6 • Number of events 1 • 12 weeks
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Gastrointestinal disorders
Indigestion
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16.7%
1/6 • Number of events 1 • 12 weeks
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Gastrointestinal disorders
Reflux
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16.7%
1/6 • Number of events 1 • 12 weeks
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place