Depression and Anxiety Trial, Not Yet Recruiting NCT07430774 Sponsor: University of Texas Southwestern Medical Center Condition: Depression and Anxiety
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Depression and Anxiety Trial, Not Yet Recruiting

NCT07430774
Not Yet Recruiting Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • People aged 12 to 18 years old at the time of screening.
  • People who have a current diagnosis of Major Depressive Disorder (a form of serious depression) recorded in their medical file by a licensed clinician.
  • People who live with a parent or legal guardian for at least half of the time.
  • People who are willing to agree to take part, with a parent or legal guardian also willing to give their consent.
  • People who are willing to follow all study requirements, including wearing a Fitbit Charge 5 device on their wrist for 7 nights, syncing it through a compatible smartphone, and completing several questionnaires and measurements.
  • People whose primary caregiver is willing to take part, including completing a questionnaire about the parent-child relationship.
  • People who are taking antidepressant medication and have been on the same stable dose for at least 4 weeks before screening.
  • People who speak English, as all study materials are in English, and whose caregiver also speaks English.
  • People who are available to attend two in-person study visits during the study period.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have a medical condition that affects heart rhythm or the nervous system's control of the heart, such as irregular heartbeat, congenital heart disease, cardiomyopathy, Type 1 or Type 2 diabetes, thyroid disorders, or moderate-to-severe sleep apnea.
  • People who take medications known to affect heart rate, including beta-blockers, calcium channel blockers, anti-arrhythmic drugs, tricyclic antidepressants, stimulants, or antipsychotic medications.
  • People who actively use substances including nicotine or tobacco, alcohol, marijuana, recreational drugs, or energy drinks.
  • People who regularly consume more than 200 mg of caffeine per day (roughly more than 4 cups of coffee or more than 2 cans of caffeinated soda per day).
  • People who have a psychotic disorder or are currently experiencing psychotic symptoms.
  • People who are currently experiencing active thoughts of suicide that require immediate attention, based on responses to a specific risk screening tool used in the study.
  • People with severe cognitive or intellectual difficulties that would prevent them from taking part in the study.
  • People who currently have a diagnosis of an eating disorder such as anorexia nervosa, bulimia nervosa, or binge eating disorder.
  • People who are currently taking part in another study that involves wearable devices or daily monitoring.
  • People who have skin conditions or sensitivities that would prevent them from wearing a device on their wrist continuously.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 7 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

If you need support right now

This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.

If you or someone else is in immediate danger, call 000.

  • Lifeline — 24/7 crisis support: 13 11 14
  • Suicide Call Back Service — 24/7 counselling: 1300 659 467
  • 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
  • Beyond Blue — 24/7 mental health support: 1300 22 4636
  • Kids Helpline — 24/7, free and private for anyone aged 5 to 25: 1800 55 1800
  • headspace — mental health support for 12 to 25 year olds: headspace.org.au
  • Emergency: 000

Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.

Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.

Contact this trial

Phone: 650-804-0602

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 July 2026
Est. completion
1 April 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Nighttime Heart Rate Variability (RMSSD)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 7 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov