PreeclampsiaEarly Phase 1NCT07715669
Antidepressant Therapy for Improved Blood Vessel Health After Preeclampsia
A Early Phase 1 study testing Paroxetine Hydrochloride and Ascorbic acid (Vitamin C) in people with Preeclampsia and Endothelial Function, run by Anna Stanhewicz, PhD at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Endothelial Function
- What is being tested?
- Paroxetine Hydrochloride and Ascorbic acid (Vitamin C)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2026to Jun 2027
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-24 years old,
- 12 weeks - 5 years post pregnancy
- one of the following:
- history of a normal pregnancy with a current diagnosis of depression,
- history of a normal pregnancy without a current diagnosis of depression,
- history of a preeclamptic pregnancy with a current diagnosis of depression
- history of preeclamptic pregnancy without a current diagnosis of depression.
Who cannot join
- history of cardiovascular, metabolic, and/or skin diseases
- current or history of tobacco/nicotine/ e-cigarette use
- history of gestational diabetes
- current antihypertensive or cholesterol-lowering medication
- currently pregnant
- allergy to materials used during the experiment (e.g. latex),
- known allergy to study drugs
- currently using SSRI medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa
Iowa City, Iowa, 52242-3521
Anna Stanhewicz, 319-467-1732, anna-stanhewicz@uiowa.edu
Willis Barr, willis-barr@uiowa.edu
About this study
Official title: Role of Antidepressant Therapy to Improve Vascular Function After Preeclampsia
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.
- Conditions
- Preeclampsia, Endothelial Function
- Being tested
- Paroxetine Hydrochloride, Ascorbic acid (Vitamin C)
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paroxetine HydrochlorideDrug
Localized delivery of paroxetine HCl to the cutaneous microvasculature via intradermal microdialysis.
Ascorbic acid (Vitamin C)Drug
Localized delivery of ascorbic acid to the cutaneous microvasculature via intradermal microdialysis.
| Study group | Role | What they receive |
|---|---|---|
| Cutaneous Vascular Response to Local Heat | Experimental | 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. Receives: Drug: Paroxetine Hydrochloride; Drug: Ascorbic acid (Vitamin C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: at the study visit, an average of 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start30 Aug 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Four groups of participants (women with a history of preeclampsia + current depression, women with a history of preeclampsia - current depression, women with a history of uncomplicated pregnancy + current depression, women with a history of uncomplicated pregnancy - current depression) complete single study visit with 4 localized intradermal microdialysis treatments.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anna Stanhewicz, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Stanhewicz, PhD, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715669
- Sponsor's protocol ID
- 202605218
- Other IDs
- 26BCDA1622718
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No