[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07715669":3,"trial-entities:NCT07715669":99,"trial-summary:NCT07715669":103},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":48,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":72,"locations":74,"central_contacts":93,"overall_officials":96,"references":97,"see_also_links":98},"NCT07715669","202605218","Antidepressant Therapy for Improved Blood Vessel Health After Preeclampsia","Role of Antidepressant Therapy to Improve Vascular Function After Preeclampsia","RECRUITING","2027-06","2026-07","2026-07-29","2026-08-30","Anna Stanhewicz, PhD","OTHER",false,"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.",null,[19,20],"Preeclampsia","Endothelial Function",[],"INTERVENTIONAL","BASIC_SCIENCE",[25],"EARLY_PHASE1",{"count":27,"type":28},40,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","Paroxetine Hydrochloride","Localized delivery of paroxetine HCl to the cutaneous microvasculature via intradermal microdialysis.",[35],"Cutaneous Vascular Response to Local Heat",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Ascorbic acid (Vitamin C)","Localized delivery of ascorbic acid to the cutaneous microvasculature via intradermal microdialysis.",[35],[41,45],{"measure":42,"description":43,"timeFrame":44},"Microvascular endothelium-dependent dilation response measured by laser-Doppler flowmetry","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",{"measure":46,"description":47,"timeFrame":44},"Nitric oxide-dependent dilation response measured by laser-Doppler flowmetry","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).",[],"FEMALE","18 Years","45 Years",true,{"inclusion":54,"exclusion":62,"raw_text":71},[55,56,57,58,59,60,61],"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.",[63,64,65,66,67,68,69,70],"history of cardiovascular, metabolic, and\u002For skin diseases","current or history of tobacco\u002Fnicotine\u002F 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","Inclusion Criteria:\n\n* 18-24 years old,\n* 12 weeks - 5 years post pregnancy\n* one of the following:\n* history of a normal pregnancy with a current diagnosis of depression,\n* history of a normal pregnancy without a current diagnosis of depression,\n* history of a preeclamptic pregnancy with a current diagnosis of depression\n* history of preeclamptic pregnancy without a current diagnosis of depression.\n\nExclusion Criteria:\n\n* history of cardiovascular, metabolic, and\u002For skin diseases\n* current or history of tobacco\u002Fnicotine\u002F e-cigarette use\n* history of gestational diabetes\n* current antihypertensive or cholesterol-lowering medication\n* currently pregnant\n* allergy to materials used during the experiment (e.g. latex),\n* known allergy to study drugs\n* currently using SSRI medications",[73],"ADULT",[75],{"facility":76,"status":8,"city":77,"state":78,"zip":79,"country":80,"contacts":81,"geoPoint":90},"University of Iowa","Iowa City","Iowa","52242-3521","United States",[82,87],{"name":83,"role":84,"phone":85,"email":86},"Anna Stanhewicz","CONTACT","319-467-1732","anna-stanhewicz@uiowa.edu",{"name":88,"role":84,"email":89},"Willis Barr","willis-barr@uiowa.edu",{"lat":91,"lon":92},41.66113,-91.53017,[94],{"name":95,"role":84,"phone":85,"email":86},"Anna Reid-Stanhewicz, PHD",[],[],[],{"nct_id":4,"conditions":100,"biomarkers":102},[101,19],"Depression",[],{"nct_id":4,"found":52,"summary":104,"prompt_version":114},{"design":105,"status":106,"heading":107,"summary":108,"follow_up":109,"word_count":110,"commitments":111,"compensation":112,"drugs_mentioned":113},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 40 women.","completed","Antidepressant Therapy for Blood Vessel Health After Preeclampsia","This study is looking at how two treatments, Paroxetine Hydrochloride (an antidepressant) and Ascorbic acid (Vitamin C), affect blood vessel health in women after pregnancy. Women who had preeclampsia (high blood pressure during pregnancy) or depression, or both, are more likely to have heart problems later. Researchers believe this might be due to changes in their blood vessels. This study will deliver these treatments directly to small blood vessels in the skin to see if they improve how well these vessels expand. You may be able to join if you are a woman between 18 and 45 years old, 12 weeks to 5 years after pregnancy, with or without a history of preeclampsia or depression. The study aims to enroll 40 participants.","The primary endpoints are measured at the study visit, an average of 4 hours, suggesting follow-up is limited to this visit.",122,"The primary endpoints are measured at the study visit, which averages 4 hours. This suggests a single visit or a short series of visits.","Not stated in the trial record.",[32,37],"v2"]