Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension
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|ClinicalTrials.gov Identifier: NCT00942708|
Recruitment Status : Completed
First Posted : July 21, 2009
Results First Posted : May 22, 2019
Last Update Posted : May 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Drug: Fluoxetine||Phase 2|
Idiopathic pulmonary arterial hypertension (PAH) is a life-threatening disorder of uncertain cause that leads to progressive right heart failure and death. Average survival has improved from about 2.8 years in the early 1990s to approximately 5-7 years with current treatments, but most patients will still die of their disease. Two classes of oral medications are approved for use in PAH: endothelin-1 antagonists, and phosphodiesterase-5 inhibitors. Both improve walk distance and symptoms in PAH, but most patients still have continued dyspnea, fatigue and significant elevations in pulmonary pressures. Those who remain severely impaired are generally started on a continuous intravenous prostacyclin. For those who are less ill but still symptomatic, few options are available.
Primary endpoint: the primary endpoint will be change in pulmonary vascular resistance (PVR) measured by right heart catheterization after three months of therapy.
- Six minute walk distance
- QIDS-SR depression scale
Safety and tolerability endpoints will include a tabulation of adverse events to include but not limited to:
- Symptomatic hypotension
- Gastrointestinal side effects
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||August 2011|
Fluoxetine will be added starting at 20 mg and titrated as tolerated to 80 mg daily.
Total dose How to take:
Week 1-2 20 mg daily Week 3-4 40 mg daily Week 5-6 40 mg BID Week 7-12 40mg BID
- Change in Pulmonary Vascular Resistance (PVR) at Three Months [ Time Frame: 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.
- Change Between Baseline and Three Month in the QIDS-SR Depression Scale [ Time Frame: 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.
- Change in Six Minute Walk Distance at 3 Months [ Time Frame: 3 months ]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.
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): NCT00942708
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Kelly M Chin, MD||UT Southwestern Medical Center|