40 Participants NeededMy employer runs this trial

Antidepressant Therapy for Preeclampsia

AR
Overseen ByAnna Reid-Stanhewicz, PHD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for women aged 18-24 who are 12 weeks to 5 years after pregnancy, with or without a history of preeclampsia and/or depression. Participants can't join if they use blood pressure or cholesterol meds, have heart/metabolic/skin diseases, allergies to study drugs/materials, currently use SSRIs, are pregnant, had gestational diabetes, or use tobacco/nicotine.

Inclusion Criteria

I am 18-24, 12 weeks to 5 years after a preeclamptic pregnancy, and not currently depressed.
I am 18-24, had a normal pregnancy 3 months to 5 years ago, and have depression now.
I am 18-24, had preeclampsia in pregnancy 12 weeks to 5 years ago, and have depression now.
See 1 more

Exclusion Criteria

I am currently taking medication for high blood pressure or cholesterol.
I have a history of heart, metabolic, or skin diseases.
I am allergic to the drugs used in this study.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cutaneous vascular response testing with local heat and various treatments including paroxetine HCl and ascorbic acid

1 day
1 visit (in-person)

Follow-up

Participants are monitored for changes in blood vessel health and depression status after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ascorbic acid (Vitamin C)
  • Paroxetine Hydrochloride

Trial Overview

The study tests whether the antidepressant paroxetine (with vitamin C) can improve blood vessel health in young women after preeclampsia. It compares groups based on their pregnancy and depression history to see how these factors affect future heart disease risk.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Cutaneous Vascular Response to Local HeatExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Anna Stanhewicz, PhD

Lead Sponsor

Trials
12
Recruited
460+