Post-Traumatic Stress Disorder (PTSD) Clinical Trials

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Role of Nitric Oxide (NO) in Endothelial Dysfunction in Premenopausal Women With Posttraumatic Stress Disorder (PTSD)

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This research study is conducted to better understand why women with post-traumatic stress disorder (PTSD) have higher risk of cardiovascular disease as they get older. This study looks at how trauma and PTSD affect blood vessels in young women by testing whether the dietary supplement beetroot juice might help improve the function of blood vessels in women suffering from PTSD.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• Women ages 18-40 (female as defined biologically)

• Premenopausal as indicated by self-report of menstrual cycles.

• Trauma-exposed with or without PTSD. Diagnostic Criteria for both trauma exposure and PTSD will be obtained via clinical interview, medical records, and self-report.

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Diagnosis of major depression (MD).

• Comorbid Psychiatric Conditions: Participants with other anxiety disorders, and bipolar disorder without psychotic features, mild to moderate traumatic brain injury, and borderline personality disorder will be included.

• Medical records will also assist in the detection of current and lifetime comorbid psychiatric conditions.

• Any over-the-counter medications must be held for 24 hours before each testing visit.

⁃ The PTSD groups must meet DSM-5 diagnostic criteria for PTSD assessed via the CAPS 5 (at least 6 symptoms: 1 B, 1 C, 2 D, and 2 E), with a total severity score of ≥25:

⁃ We will enroll participants as long as they are stable on meds (no changes within the past 3 months). Many participants are often on psychiatric meds, but still have PTSD symptoms. It really isn't that this is an untreated sample. It is more than that it includes people actively symptomatic, regardless of current treatment. Participants will not be required to stop any psychiatric medications.

Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Ida-Arlaine Fonkoue, MD, PhD, MsCR
fonko001@umn.edu
612-626-2520
Time Frame
Start Date: 2026-02-18
Estimated Completion Date: 2028-05-01
Participants
Target number of participants: 30
Treatments
Experimental: Beetroot Juice
Placebo_comparator: Placebo Juice
Related Therapeutic Areas
Sponsors
Leads: University of Minnesota

This content was sourced from clinicaltrials.gov

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