Antidepressant Therapy for Improved Blood Vessel Health After Preeclampsia

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Anna Stanhewicz, PhD
Study ID
NCT07715669
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Endothelial Function
  • Preeclampsia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Paroxetine Hydrochloride — DRUG
    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 Details

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.

Key Dates

First listed
Jul 20, 2026
Start date
Aug 30, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Cutaneous Vascular Response to Local Heat
    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.

Primary Outcome Measure

Microvascular endothelium-dependent dilation response measured by laser-Doppler flowmetry [ Time Frame: at the study visit, an average of 4 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242-3521
Anna Stanhewicz
[email protected]
319-467-1732
Willis Barr
[email protected]

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By research site
University of Iowa· Iowa City, IA

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