- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07715669
Antidepressant Therapy for Improved Blood Vessel Health After Preeclampsia
Role of Antidepressant Therapy to Improve Vascular Function After Preeclampsia
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Anna Reid-Stanhewicz, PHD
- Phone Number: 319-467-1732
- Email: anna-stanhewicz@uiowa.edu
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52242-3521
- Recruiting
- University of Iowa
-
Contact:
- Anna Stanhewicz
- Phone Number: 319-467-1732
- Email: anna-stanhewicz@uiowa.edu
-
Contact:
- Willis Barr
- Email: willis-barr@uiowa.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
18-24 years old, 12 weeks - 5 years post pregnancy one of the following:
- a history of a normal pregnancy with a current diagnosis of depression,
- a history of a normal pregnancy without a current diagnosis of depression,
- 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
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
Localized delivery of paroxetine HCl to the cutaneous microvasculature via intradermal microdialysis.
Localized delivery of ascorbic acid to the cutaneous microvasculature via intradermal microdialysis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Microvascular endothelium-dependent dilation response measured by laser-Doppler flowmetry
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Pregnancy Complications
- Hypertension, Pregnancy-Induced
- Pre-Eclampsia
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Carbohydrates
- Sugar Acids
- Acids, Acyclic
- Carboxylic Acids
- Hydroxy Acids
- Piperidines
- Ascorbic Acid
- Paroxetine
Other Study ID Numbers
- 202605218
- 26BCDA1622718 (Other Grant/Funding Number: American Heart Association)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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