Post Traumatic Stress Disorder study: Beetroot Juice
Official title Nitric Oxide (NO) and Endothelial Dysfunction in Women With PTSD
ClinicalTrials.gov ID: NCT07485231
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only
You may be able to join if
- 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...
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Diagnosis of major depression (MD).
You likely can't join if
- Non-biologically female people who may otherwise identify as women
- Individuals who are taking hormone replacement therapy.
- Pregnant, breastfeeding, or planning to become pregnant during the duration of the study
- Individuals taking any types of hormonal contraceptives.
- Self-reported Medical conditions: hypertension, diabetes, heart disease, vascular disease, ongoing illicit drug use, excessive alcohol use (\>2...
- Medications for PTSD or other cardiovascular diseases or any medication known to affect vascular function and central sympathetic output, such as...
See the full eligibility criteria
- 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)...
- Non-biologically female people who may otherwise identify as women
- Individuals who are taking hormone replacement therapy.
- Pregnant, breastfeeding, or planning to become pregnant during the duration of the study
- Individuals taking any types of hormonal contraceptives.
- Self-reported Medical conditions: hypertension, diabetes, heart disease, vascular disease, ongoing illicit drug use, excessive alcohol use (\>2 drinks per day), hyperlipidemia, autonomic dysfunction, any serious...
- Medications for PTSD or other cardiovascular diseases or any medication known to affect vascular function and central sympathetic output, such as antihypertensive medications (beta blockers, calcium channel blockers...
- Psychiatric Comorbidities: Ongoing substance abuse will be excluded because of the sympathoexcitatory effect of illicit drugs such as cocaine and methamphetamines that exert a powerful pressor and direct...
- Psychotic and dissociative disorders will be excluded due to concerns regarding comprehension and adherence.
- The inability or unwillingness to abstain from nicotine use for at least 12 hours prior to physiologic studies (visits 1 and 2), to eliminate sympathoexcitatory effects of nicotine (half-life of 2 hours).
The study team makes the final eligibility decision.
Where it is enrolling
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Minneapolis, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.