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Antidepressant Therapy's Impact on Vascular Function in Post-Preeclampsia Women

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Study Aim

This early phase study aims to evaluate the impact of antidepressant therapy on vascular function, specifically microvascular and nitric oxide-dependent dilation responses, in women who have previously experienced preeclampsia.

What is being tested

Paroxetine Hydrochloride

+ Ascorbic acid (Vitamin C)

Drug
Who is being recruted

Urogenital Diseases+2

+ Female Urogenital Diseases and Pregnancy Complications

+ Pregnancy Complications

From 18 to 45 Years
See all eligibility criteria
How is the trial designed

Basic Science Study

Early Phase 1
Interventional
Study Start: August 2026
See protocol details

Summary

Principal SponsorAnna Stanhewicz, PhD
Study ContactAnna Reid-Stanhewicz, PHDMore contacts
Last updated: July 20, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 30, 2026

Actual date on which the first participant was enrolled.

Preeclampsia is a condition where a pregnant woman experiences high blood pressure and other complications. Women who have had preeclampsia are more likely to develop heart disease and depression later in life. This might be due to damage to their blood vessels during pregnancy. This study aims to understand how preeclampsia and depression are linked to changes in blood vessel health. It also explores if treating depression can improve blood vessel health in women who've had preeclampsia, potentially reducing their risk of heart disease. The study compares blood vessel function in women who've had preeclampsia with those who haven't, and in women with and without depression. It uses a technique called laser-Doppler flowmetry to measure how well blood vessels respond to different treatments. This involves heating the skin and observing blood flow changes. The study also looks at how a drug used to treat depression, called L-NAME, affects blood vessel function. The primary outcomes of the study are the responses of blood vessels to local heating and to L-NAME.

NCT07715669
Principal SponsorAnna Stanhewicz, PhD
Study ContactAnna Reid-Stanhewicz, PHDMore contacts
Last updated: July 20, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsPregnancy ComplicationsHypertension, Pregnancy-InducedPre-Eclampsia

Criteria

Inclusion Criteria: 18-24 years old, 12 weeks - 5 years post pregnancy one of the following: 1. a history of a normal pregnancy with a current diagnosis of depression, 2. a history of a normal pregnancy without a current diagnosis of depression, 3. a history of a preeclamptic pregnancy with a current diagnosis of depression, 4) and 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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University of Iowa

Iowa City, United StatesOpen University of Iowa in Google Maps
Recruiting
One Study Center