Recruiting
Early Phase 1

Depression with Preeclampsia

Sponsor:

Anna Stanhewicz, PhD

Code:

NCT07715669

Conditions

Preeclampsia

Endothelial Function

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Paroxetine Hydrochloride

Ascorbic acid (Vitamin C)

Study Details

Brief 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. 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

Study ID

NCT07715669

Start date

Aug 30, 2026

Status verified date

Jul, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Paroxetine Hydrochloride

Localized delivery of paroxetine HCl to the cutaneous microvasculature via intradermal microdialysis.

Ascorbic acid (Vitamin C)

Localized delivery of ascorbic acid to the cutaneous microvasculature via intradermal microdialysis.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242-3521

Contacts

More Information

Sponsor

Anna Stanhewicz, PhD

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by Anna Stanhewicz, PhD on 2026-07-29.