BridgeMD
New treatment option for Situational Anxiety
Official title Decentralized Study to Evaluate a Dietary Supplement for Episodes of Mild Acute Stress in Healthy People
ClinicalTrials.gov ID: NCT07511088
What this study is testing
- What it's testing
- The purpose of this decentralized, two-arm, double-blinded, crossover clinical study is to test the efficacy of a supplement to reduce symptoms of acute stress or situational anxiety in healthy volunteers. The main questions it aims to answer are: 1.
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
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 60. Healthy volunteers may be eligible.
You may be able to join if
- Female and male people aged \>18 and \<60 years.
- Self-reported experience of episodic stress or situational anxiety of ≥1 x per week.
- Score of ≥ 40 on a self-assessment of typical anxiety on a Visual Analog Scale where 0 represents "not stressed or anxious" and 100 represents...
- Score of ≥ 20 on the Positive Reactivity component of the Perth Emotional Reactivity Scale- Short Form (PERS-S).
- Ability to complete surveys on the Alethios digital platform.
You likely can't join if
- Score of \> 9 on the Patient Health Questionnaire (PHQ-9) or any response \> 0 on question 9 of the PHQ-9.
- Score \> 24 on the Hamilton Anxiety Scale (HAM-A).
- History of severe psychiatric or medical conditions that would interfere with participation.
- Use of \>14 alcoholic drinks per week.
- Subject is a regular cannabis user, as defined as equal to or greater than 2 times per week over the prior 6 weeks.
- Individuals with a history of drug abuse or dependence within the past 6 months.
See the full eligibility criteria
- Female and male people aged \>18 and \<60 years.
- Self-reported experience of episodic stress or situational anxiety of ≥1 x per week.
- Score of ≥ 40 on a self-assessment of typical anxiety on a Visual Analog Scale where 0 represents "not stressed or anxious" and 100 represents "extremely stressed or anxious."
- Score of ≥ 20 on the Positive Reactivity component of the Perth Emotional Reactivity Scale- Short Form (PERS-S).
- Ability to complete surveys on the Alethios digital platform.
- Subject is only taking well-established, stable doses of prescription and non-prescription medications that are not indicated to treat anxiety disorder.
- Subject is in generally good health as determined by a review of self-reported medical history and in the opinion of the Principal Investigator.
- Women of child-bearing potential must agree to use a medically approved form of birth control during the study. Acceptable methods of birth control include hormonal - oral (pill), implantable, injectable (shot), ring...
- Subject agrees to abstain from cannabis use for the duration of the study period
- Subject agrees to maintain current dietary habits and abstain from using dietary supplements or herbal products thought to affect a sense of calming, including ashwagandha, L-theanine, or St. John's Wort, for the...
- Individual is aware of the procedures and agrees to participate in the study.
- Participant understands and is willing to sign an Informed eConsent in conformance with 21 CFR Part 50: "Protection of Human Participants."
- Score of \> 9 on the Patient Health Questionnaire (PHQ-9) or any response \> 0 on question 9 of the PHQ-9.
- Score \> 24 on the Hamilton Anxiety Scale (HAM-A).
- History of severe psychiatric or medical conditions that would interfere with participation.
- Use of \>14 alcoholic drinks per week.
- Subject is a regular cannabis user, as defined as equal to or greater than 2 times per week over the prior 6 weeks.
- Individuals with a history of drug abuse or dependence within the past 6 months.
- Changes to medication treatment for any health condition within the prior 3 months.
- Use of any prescription medication for anxiety.
- Any diagnosis of a mental health condition in the prior 3 months.
- Unstable medical conditions.
- Known hypersensitivity to study product.
- Participant is pregnant, planning to become pregnant, or breastfeeding.
- Pregnant or lactating women or women of child-bearing potential unwilling to use a medically approved form of birth control.
- Inability to comply with digital study requirements.
- Participation in a clinical study within 30 days prior to randomization
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, 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 - 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 all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.