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Blood and wearable data may predict depression swings

NCT ID NCT05910957

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study looks at whether combining information from blood samples and smartwatch data can help diagnose major depression and predict when a person moves between active depression and treated depression. Researchers will track symptoms using standard depression rating scales. The goal is to find objective markers that could improve how depression is detected and managed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a way to diagnose depression using objective data from blood and wearables, and to predict when someone might relapse.
What could go wrong
This is a small pilot study with only 40 participants, so results may not apply to everyone. It is exploratory and not designed to prove a treatment works.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subjects will be recruited from an ongoing cohort study at Mayo Florida "Wearable Augmented Prediction of Burnout in Nurses: A Synergy of Engineering, Bioethics, Nursing and Wellness Sciences" (BROWNIE Study)

Ages

20 to 62 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participated in the BROWNIE study. * DSM-5 diagnostic criteria are met for unipolar, non-psychotic MDD (excluding controls). * A score of \> 10 on the QIDS-C and QIDS-SR (equivalent to 13 or greater on HAM-D17) given that when medication exceeds the effect of placebo in primary care participants have a HAM-D17 \>12 (excluding controls). * Antidepressant treatment is deemed appropriate by a study clinician (excluding controls). * Smart watch wear time is at least 70% during their participation in the BROWNIE study. Exclusion Criteria: * Subjects with medical contraindications that preclude treatment with study drugs will be excluded. * Patients with schizophrenia, schizoaffective disorder, or who have bipolar I or II disorder (or another specified or unspecified bipolar spectrum disorder) will be excluded because they have a primary psychiatric condition that requires a different initial treatment. * Subjects currently on antidepressant medication with subtherapeutic results in terms of depression management will undergo a medication taper and discontinuation prior to initiation of a new study medication. The subject will be closely monitored by the study clinician during the medication taper and discontinuation phase. The medication taper is left up to the study clinician's discretion. Study subjects who cannot be safely tapered from their medication or experience adverse effects during the taper will be excluded from the study. * Subjects who have an active substance use disorder will be excluded. An active substance use disorder will be defined as meeting DSM-5 diagnostic criteria for any active substance use disorder. Persons meeting DSM-5 diagnostic criteria for a substance use disorder in full remission (\>12 months) and a negative urine drug of abuse screen at the screening visit or before the baseline study visit will be considered eligible. Persons with a positive urine drug of abuse screen may participate in the study if they do not meet DSM-5 diagnostic criteria for a substance use disorder. * Subjects unable to give informed consent or who are unwilling or unable to comply with study requirements are excluded. * Pregnant subjects will be excluded. * Subjects who are currently breastfeeding and who plan to continue breastfeeding will be excluded. * Subjects who are psychiatrically hospitalized or in a mental health crisis requiring urgent care or psychiatric hospitalization. * Study subjects currently on antipsychotic medications (e.g., typical, and atypical antipsychotic drugs) taken for primary psychotic illness or affective psychosis will be excluded. * Study subjects taking mood stabilizing agents (e.g., lithium, carbamazepine, valproate, lamotrigine, gabapentin, or other anticonvulsants) taken specifically for bipolar spectrum disorders are not eligible for participation.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.