Anxiety DisordersNCT07340281
Biomarkers for Exercise
A study testing Exercise Intervention in people with Anxiety Disorders, run by NYU Langone Health at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2026to 15 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: Examining Novel Biomarkers of Neuroplasticity Associated With Exercise in Adults With Anxiety Disorders
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.
- Conditions
- Anxiety Disorders
- Being tested
- Exercise Intervention
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
Exercise intervention is delivered in weekly individual sessions virtually for the 4-week intervention period. Sessions range from 25-45 minutes. The sessions serve as touch base points to review exercise for the week, plan for the coming week, problem-solve obstacles, and discuss various motivational strategies to help with an exercise routine. Participants are prescribed 150 minutes of moderate intensity exercise per week to be completed at home.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with Anxiety Disorder | Experimental | All participants will complete the 4-week exercise intervention in which they'll be prescribed 150 minutes of moderate intensity exercise per week at home, which will be measured using Fitbits. Receives: Behavioral: Exercise Intervention |
| Control Individuals | Active comparator | All participants will complete the 4-week exercise intervention in which they'll be prescribed 150 minutes of moderate intensity exercise per week at home, which will be measured using Fitbits. Receives: Behavioral: Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acetyl-L-carnitine (LAC) Levels
Levels of LAC isolated from neuronal exosomes from plasma blood draws.
Measured: Week 4
Interleukin-6 (IL-6) Levels
Levels of IL-6 isolated from neuronal exosomes from plasma blood draws.
Measured: Week 4
Secondary outcomes (10)
Continuously measured moderate/vigorous minutes of exercise
Information collected via Fitbit.
Measured: Up to Week 4
7-Day Physical Activity Recall
Measurement of total weekly metabolic equivalent of task (MET)-hours.
Measured: Baseline, Week 2, Week 4
Overall Anxiety Severity and Impairment Scale (OASIS)
OASIS is a 5-item assessment of anxiety severity and impairment over the past week; each item is rated on a Likert scale from 0-4. The total score is the sum of responses and ranges from 0-20; higher scores indicate greater anxiety severity and impairment.
Measured: Baseline, Week 2, Week 4
Anxiety Sensitivity Index (ASI-3) Score
ASI-3 is an 18-item assessment of anxiety severity over the past week; each item is rated on a Likert scale from 0-4. The total score is the sum of responses and ranges from 0-72; higher scores indicate greater anxiety severity.
Measured: Baseline, Week 2, Week 4
Quick Inventory of Depressive Symptomatology (QIDS) Score
QIDS is a 16-item assessment of depressive symptomatology; each item is rated on a Likert scale from 0-3. The total score is the sum of responses from each of the 9 domains and ranges from 0-27; higher scores indicate greater severity of depressive symptomatology.
Measured: Baseline, Week 2, Week 4
Perceived Stress Scale (PSS) Score
PSS is a 10-item assessment of perceived stress; each item is rated on a scale from 0-4. The score is the sum of responses ranges from 0 to 40 with higher scores indicating higher perceived stress.
Measured: Baseline, Week 2, Week 4
Childhood Trauma Questionnaire
CTQ is a 28-item assessment of childhood trauma. The scale comprises five sub-scales; the score to each subscale ranges from 5-25; the total score is the sum of the sub-scales and ranges from 25-125; higher scores indicate more frequent/severe childhood trauma experiences.
Measured: Baseline, Week 2, Week 4
Insomnia Severity Index (ISI) Score
ISI is a 7-item assessment of insomnia; each item is rated on a scale from 0-4. The total score is the sum of responses and ranges from 0-28; higher scores indicate greater insomnia severity.
Measured: Baseline, Week 2, Week 4
International Physical Activity Questionnaire (IPAQ) Score
IPAQ is an assessment of overall activity levels; the total score is expressed as METs (Metabolic Equivalents), a unit representing energy cost, where 1 MET is resting energy expenditure.
Measured: Baseline, Week 2, Week 4
Body Mass Index (BMI)
Measured: Baseline, Week 2, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start6 Mar 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristin Szuhany, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340281
- Sponsor's protocol ID
- 25-01561
- Status last verified
- Mar 2026
- First submitted
- 6 Jan 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified data will be made available if requested.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Novel Biomarkers of Neuroplasticity Associated With Exercise in Adults With Anxiety Disorders
- ClinicalTrials.gov ID
- NCT07340281
- Acronym / sponsor ID
- 25-01561
- Conditions
- Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with Anxiety Disorder | Experimental | Behavioral: Exercise InterventionAll participants will complete the 4-week exercise intervention in which they'll be prescribed 150 minutes of moderate intensity exercise per week at home, which will be measured using Fitbits. |
| Control Individuals | Active comparator | Behavioral: Exercise InterventionAll participants will complete the 4-week exercise intervention in which they'll be prescribed 150 minutes of moderate intensity exercise per week at home, which will be measured using Fitbits. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
- Primary psychiatric diagnosis of generalized anxiety disorder (GAD), social anxiety disorder, or panic disorder
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionExercise intervention is delivered in weekly individual sessions virtually for the 4-week intervention period. Sessions range from 25-45 minutes. The sessions serve as touch base points to review exercise for the week, plan for the coming week, problem-solve obstacles, and discuss various motivational strategies to help with an exercise routine. Participants are prescribed 150 minutes of moderate intensity exercise per week to be completed at home. | Behavioural | Control Individuals, Individuals with Anxiety Disorder |
Primary outcome
Acetyl-L-carnitine (LAC) Levels
Time frame: Week 4
Levels of LAC isolated from neuronal exosomes from plasma blood draws.
Interleukin-6 (IL-6) Levels
Time frame: Week 4
Levels of IL-6 isolated from neuronal exosomes from plasma blood draws.
10 secondary outcomes
Continuously measured moderate/vigorous minutes of exercise
Time frame: Up to Week 4
7-Day Physical Activity Recall
Time frame: Baseline, Week 2, Week 4
Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: Baseline, Week 2, Week 4
Anxiety Sensitivity Index (ASI-3) Score
Time frame: Baseline, Week 2, Week 4
Quick Inventory of Depressive Symptomatology (QIDS) Score
Time frame: Baseline, Week 2, Week 4
Perceived Stress Scale (PSS) Score
Time frame: Baseline, Week 2, Week 4
Childhood Trauma Questionnaire
Time frame: Baseline, Week 2, Week 4
Insomnia Severity Index (ISI) Score
Time frame: Baseline, Week 2, Week 4
International Physical Activity Questionnaire (IPAQ) Score
Time frame: Baseline, Week 2, Week 4
Body Mass Index (BMI)
Time frame: Baseline, Week 2, Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No. Deidentified data will be made available if requested.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristin Szuhany, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Anxiety Disorders, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristin Szuhany, PhD (646-754-5161, Kristin.szuhany@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acetyl-L-carnitine (LAC) Levels (time frame: Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.