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New treatment option for Anxiety Disorders
Official title Biomarkers for Exercise
ClinicalTrials.gov ID: NCT07340281
What this study is testing
- What it's testing
- The overarching objective is to examine the brain-based biological mechanistic pathway by which exercise exerts anxiolytic effects. The investigators will measure brain-derived markers of mitochondrial metabolism (acetyl-L-carnitine [LAC]) and inflammation (interleukin-6 [IL-6]) using innovative technology to isolate neuronal exosomes.
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 50. Healthy volunteers may be eligible.
You may be able to join if
- For both participant groups: To be eligible to participate in this study, an individual must meet all of the following criteria:
- Between 18-50 years of age
- Currently sedentary (≤60 minutes of moderate intensity exercise per week for the past 3 months)
- Capable and willing to provide informed consent For anxiety disorder participant group, an individual must also meet:
- Primary psychiatric diagnosis of generalized anxiety disorder (GAD), social anxiety disorder, or panic disorder
You likely can't join if
- Lifetime history of Bipolar I or II or any psychotic disorder
- Bulimia or anorexia in the past 3 months
- Alcohol or substance use disorder in the past 3 months
- Current major depressive disorder (past is allowed)
- Current neurologic disorder
- High current suicide risk (active suicidal ideation with plan and intent) as indicated by a score of ≥4 on the Columbia Suicide Severity Rating Scale...
See the full eligibility criteria
- For both participant groups: To be eligible to participate in this study, an individual must meet all of the following criteria:
- Between 18-50 years of age
- Currently sedentary (≤60 minutes of moderate intensity exercise per week for the past 3 months)
- Capable and willing to provide informed consent For anxiety disorder participant group, an individual must also meet:
- Primary psychiatric diagnosis of generalized anxiety disorder (GAD), social anxiety disorder, or panic disorder
- Lifetime history of Bipolar I or II or any psychotic disorder
- Bulimia or anorexia in the past 3 months
- Alcohol or substance use disorder in the past 3 months
- Current major depressive disorder (past is allowed)
- Current neurologic disorder
- High current suicide risk (active suicidal ideation with plan and intent) as indicated by a score of ≥4 on the Columbia Suicide Severity Rating Scale (C-SSRS) consistent with a need for referral to higher level of care
- Participation in concurrent evidence-based therapy (e.g., cognitive behavioral therapy) targeting anxiety and/or depression (supportive therapy and couples therapy are allowed)
- Risk for exercise according to the Physical Activity Readiness Questionnaire with excluded active medical conditions including heart conditions, lung disease, bone/joint problems, or seizures
- Women who are currently pregnant or plan to become pregnant during the duration of the study
- current psychiatric medication
- Current substance abuse or positive urine toxicology screen (recreational use of marijuana is permitted based on clinical assessment on the MINI structured diagnostic interview that it does not meet criteria for...
- Active infection Non-psychiatric controls who meet the following criteria will be excluded from participation in this study:
- Current psychiatric condition assessed by the MINI
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, 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 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, 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.