An Early Phase 1 interventional study of Paroxetine Hydrochloride and Ascorbic acid (Vitamin C) in Preeclampsia and Endothelial Function, sponsored by Anna Stanhewicz, PhD. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Anna Stanhewicz, PhD · Early Phase 1, Interventional, and Basic science
Preeclampsia is a condition in pregnancy where a woman develops high blood pressure and other complications. Women who develop preeclampsia are 4 times more likely to have heart disease later in life. They are also more likely to have depression after pregnancy. Why they are more likely to develop these conditions is not known. It may be because their blood vessels were damaged during pregnancy. Changes in blood vessel health can predict heart disease. These changes have been recorded after pregnancy in women who had preeclampsia. These changes have also been recorded in women who have depression. In the previous phase of this award, we found that women who had preeclampsia in pregnancy had changes in blood vessel health after pregnancy. We also found that if these women were taking a medicine to treat depression, their blood vessel health was normal. This could mean that treatment for depression can also increase blood vessel health in women who had preeclampsia. In this project we will study how changes in blood vessel health are related to preeclampsia and depression in women who have had both. We will also study how medicine to treat depression can improve blood vessel health after preeclampsia. We will do this by measuring how blood vessels work in women who have had preeclampsia compared to women who did not, and in women who have depression and women who do not. This will tell us more about why risk for depression and heart disease is higher in women who have had preeclampsia. It will also help us understand if medicine for depression can reduce cardiovascular disease risk after preeclampsia.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 40 is below the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Anna Stanhewicz, PhD is the lead sponsor of 15 studies on the registry; 8 are open to participants now.
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All women will complete the same protocol, regardless of pregnancy history and depression status. Four intradermal microdialysis fibers will be placed in the ventral forearm for the local delivery of: (1) lactated Ringer's (control), (2) paroxetine HCl, (3) ascorbic acid, or (4) paroxetine HCl + ascorbic acid. Skin blood flow will be measured with laser-Doppler flowmetry directly over each microdialysis fiber during a standard local heating protocol to 42 degrees Celsius. Once a stable plateau in blood flow has been reached, each site is perfused with L-NAME to inhibit nitric oxide synthase. Following a post-L-NAME plateau, maximal dilation is induced by perfusing sodium nitroprusside and increasing local temperature to 43 degrees Celsius.
Drug: Paroxetine Hydrochloride · Drug: Ascorbic acid (Vitamin C)
Localized delivery of paroxetine HCl to the cutaneous microvasculature via intradermal microdialysis.
Localized delivery of ascorbic acid to the cutaneous microvasculature via intradermal microdialysis.
Microvascular endothelium-dependent dilation response measured by laser-Doppler flowmetry
Cutaneous vascular conductance responses to local heating over a microdialysis fiber receiving treatments compared to lactated Ringer's solution (control).
Time frame: at the study visit, an average of 4 hours
Nitric oxide-dependent dilation response measured by laser-Doppler flowmetry
Difference in cutaneous vascular conductance between local heating plateau and post-L-NAME plateau within each treated microdialysis site compared to lactated Ringer's (control).
Time frame: at the study visit, an average of 4 hours
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Paroxetine · Ascorbic Acid
Anna Stanhewicz, PhD