Exercise effects on brain biomarkers in adults with anxiety
Examining Novel Biomarkers of Neuroplasticity Associated With Exercise in Adults With Anxiety Disorders
This program will test whether a structured exercise routine changes brain-derived biomarkers (mitochondrial LAC and inflammatory IL-6) in sedentary adults with generalized, social, or panic anxiety.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07340281 on ClinicalTrials.gov |
What this trial studies
This interventional study enrolls sedentary adults aged 18–50 who have a primary diagnosis of generalized anxiety disorder, social anxiety disorder, or panic disorder. Participants will follow a supervised exercise intervention while researchers collect blood samples and isolate neuronal exosomes to measure acetyl-L-carnitine (LAC) and interleukin-6 (IL-6) as markers of mitochondrial metabolism and inflammation. The study aims to see if these brain-specific biomarkers change with exercise in a way that could explain anxiety reduction. The protocol includes careful psychiatric and medical screening to exclude bipolar or psychotic disorders, recent eating or substance use disorders, current major depression, high suicide risk, and neurologic disorders, and is conducted at NYU Langone Health.
Who should consider this trial
Good fit: Ideal candidates are sedentary adults aged 18–50 with a primary diagnosis of generalized anxiety disorder, social anxiety disorder, or panic disorder who can provide informed consent and pass the study's safety screenings.
Not a fit: People with bipolar or psychotic disorders, recent eating disorders, recent substance use disorders, current major depression, high suicide risk, neurologic disorders, those already exercising regularly, or those unable to attend on-site visits are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, this work could identify measurable brain markers that help tailor or validate exercise-based approaches for people with anxiety.
How similar studies have performed: Physical activity has been shown to reduce anxiety and influence inflammatory markers, but measuring LAC and IL-6 within neuronal exosomes as a brain-specific mechanistic pathway is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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 cannabis use disorder) * 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
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Kristin Szuhany, PhD — NYU Langone Health
- Study coordinator: Kristin Szuhany, PhD
- Email: Kristin.szuhany@nyulangone.org
- Phone: 646-754-5161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.