Exercise effects on brain biomarkers in adults with anxiety

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.