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?

This trial explores whether the common antidepressant Paroxetine Hydrochloride can improve blood vessel health in women who experienced preeclampsia during pregnancy and may also have depression. Preeclampsia causes high blood pressure and other issues during pregnancy and may increase the risk of heart disease and depression later on. The trial will test the medicine's effect on blood flow in the skin, using a heating method to observe blood vessel response. Women who had a baby 12 weeks to 5 years ago and either had preeclampsia, depression, or neither might be suitable for this study. As an Early Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown mixed results regarding the safety of paroxetine hydrochloride, the treatment under investigation in this trial. Research indicates that using paroxetine during the first trimester of pregnancy might slightly increase the risk of heart defects in babies, from a typical 1% to about 2%. However, many studies have found no major link between paroxetine and birth defects beyond this.

Paroxetine is an antidepressant classified as an SSRI (selective serotonin reuptake inhibitor), generally considered safe for other uses. Nonetheless, evidence suggests that using paroxetine during pregnancy could increase the chance of high blood pressure, sometimes related to preeclampsia.

As for ascorbic acid, or Vitamin C, studies show it doesn't reduce the risk of preeclampsia when used alone. High doses are not recommended during pregnancy to prevent problems. However, Vitamin C is generally safe in regular amounts and is important for overall health.

In this early trial phase, researchers continue to study these treatments closely to better understand their safety, but previous uses provide some insights. Discussing any concerns with a healthcare provider is essential.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores how paroxetine hydrochloride, traditionally an antidepressant, might affect blood flow in women with preeclampsia. Unlike standard treatments for preeclampsia, which typically focus on managing blood pressure, this study investigates paroxetine's impact on vascular responses. By examining how this drug influences nitric oxide pathways and skin blood flow, the trial aims to uncover potential new ways to manage or even treat preeclampsia, a condition with limited therapeutic options. This innovative approach could lead to breakthroughs in how we understand and address preeclampsia using a drug with a known safety profile.

What evidence suggests that this trial's treatments could be effective for preeclampsia?

Research shows that paroxetine, a medication for depression, helps by boosting serotonin levels, easing depression and anxiety symptoms. Early studies suggest that women who took paroxetine after experiencing preeclampsia had healthier blood vessels, indicating potential heart health benefits. In this trial, participants will receive paroxetine alone, ascorbic acid alone, or a combination of both. Past studies have shown that Vitamin C, also known as ascorbic acid, has not been effective in preventing preeclampsia. It is important to note that using paroxetine with Vitamin C has not been proven to prevent preeclampsia. However, the potential benefit of paroxetine on blood vessel health after preeclampsia remains an interesting area of research.678910

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+

Citations

Vitamins C, E Fail to Prevent Preeclampsia

Supplementation did not reduce the risk of preeclampsia (relative risk 1.0), eclampsia (RR 1.5), or severe gestational hypertension (RR 0.8).

Vitamin C and vitamin E in pregnant women at risk for pre- ...

Concomitant supplementation with vitamin C and vitamin E does not prevent pre-eclampsia in women at risk, but does increase the rate of babies ...

Vitamins C and E to prevent complications of pregnancy- ...

Outcome data were available for 9969 women. There was no significant difference between the vitamin and placebo groups in the rates of the ...

Combined Vitamin C and E Supplementation During ...

This review assessed the effects of combined vitamin C and E supplementation during pregnancy on pre-eclampsia and major adverse infant outcomes.

(PDF) ACTS Study Group Vitamins C and E and the risks of ...

Supplementation with vitamins C and E during pregnancy does not reduce the risk of preeclampsia in nulliparous women, the risk of intrauterine ...

Vitamin C and the risk of preeclampsia - Results from ...

The OR for extreme quartiles of plasma ascorbic acid (<42.5 vs ≥ 63.3 μmol/liter) was 2.3 (95% CI = 1.1-4.6). Compared with women in the highest quartile, ...

The effects of vitamin C supplementation on pre-eclampsia in ...

We do not recommend the use of high dose vitamin C in pregnancy to prevent pre-eclampsia or other adverse maternal and neonatal outcomes.

Vitamins C and E and the Risks of Preeclampsia and ...

Our results indicate that daily supplementation with 1000 mg of vitamin C and 400 IU of vitamin E does not reduce the risk of preeclampsia in ...

Vitamins C and E and the risks of preeclampsia ...

Supplementation with vitamins C and E during pregnancy does not reduce the risk of preeclampsia in nulliparous women, the risk of intrauterine ...

Vitamin C supplementation in pregnancy

The risk of clinical preeclampsia was reduced in subgroup analysis of women with low baseline serum vitamin C concentrations, but this finding did not reach ...