Antidepressant Therapy for Improved Blood Vessel Health After Preeclampsia

NCT07715669 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: 20260521826BCDA1622718
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  at the study visit, an average of 4 hours

Study Arms (1)

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.

Drug: Paroxetine Hydrochloride; Drug: Ascorbic acid (Vitamin C)

Interventions

Paroxetine Hydrochloride DRUG

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

Cutaneous Vascular Response to Local Heat

Ascorbic acid (Vitamin C) DRUG

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

Cutaneous Vascular Response to Local Heat

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old,
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Anna Stanhewicz, PhD: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242-3521, United States

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Paroxetine; Ascorbic Acid

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Central Study Contacts

Anna Reid-Stanhewicz, PHD

CONTACT

319-467-1732; anna-stanhewicz@uiowa.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

US (1)