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Antidepressant Therapy for Improved Blood Vessel Health After Preeclampsia

27. juli 2026 oppdatert av: Anna Stanhewicz, PhD

Role of Antidepressant Therapy to Improve Vascular Function After Preeclampsia

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Tidlig fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Paroxetine Hydrochloride
Localized delivery of paroxetine HCl to the cutaneous microvasculature via intradermal microdialysis.
Legemiddel: Ascorbic acid (Vitamin C)
Localized delivery of ascorbic acid to the cutaneous microvasculature via intradermal microdialysis.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Microvascular endothelium-dependent dilation response measured by laser-Doppler flowmetry
Tidsramme: at the study visit, an average of 4 hours
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
Tidsramme: at the study visit, an average of 4 hours
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Anna Stanhewicz, PhD

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. august 2026

Primær fullføring (Antatt)

1. mars 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

15. juli 2026

Først innsendt som oppfylte QC-kriteriene

15. juli 2026

Først lagt ut (Faktiske)

20. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 202605218
  • 26BCDA1622718 (Annet stipend/finansieringsnummer: American Heart Association)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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