Major Depressive DisorderNCT05910957
Multi-Omic, Clinomic and Digitomic Attributes of Major Depression for Integrative Analytics
An observational study of Major Depressive Disorder and Unipolar, Non-psychotic Major Depressive Disorder, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to see if information from blood and data from smartwatches can be combined to help diagnose depression and determine if transitions between active depression and treated depression can be predicted. Read more about this study
- Who is it for?
- Ages 20 to 62 years
- Conditions the study is for
- Major Depressive Disorder, Unipolar, Non-psychotic Major Depressive Disorder
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2023to 6 Dec 2027
- Phase
- Observational
- 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 20 to 62 years
- All sexes
- Adult
Study population: 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)
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Omic, Clinomic and Digitomic Attributes of Major Depression for Integrative Analytics: the MACADAMIA Pilot Study
The purpose of this research is to see if information from blood and data from smartwatches can be combined to help diagnose depression and determine if transitions between active depression and treated depression can be predicted.
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-depressed controls | Subjects without depression will fill out questionnaires about their general health and wellbeing, quality of life, mental health, emotional health, suicide risk, support system, and childhood experiences. Smartwatch data will also be collected to monitor step count, sleep quality, heart rate (resting and active), and activity rates. | |
| Antidepressant-treated adults | Subjects diagnosed with depression will fill out questionnaires about their general health and wellbeing, quality of life, mental health, emotional health, suicide risk, support system, and childhood experiences. Smartwatch data will also be collected to monitor step count, sleep quality, heart rate (resting and active), and activity rates. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quick Inventory of Depressive Symptoms-Clinician Rated (QIDS-CR) scale
The Quick Inventory of Depressive Symptoms-Clinician Rated is used for rating the severity of depressive symptoms. Possible scores range from 0 to 27, with higher scores indicating greater severity of depression.
Measured: Baseline, 4 weeks, and 8 weeks
Secondary outcomes (1)
Change in Hamilton Depression Rating Scale
The Hamilton Depression Rating Scale is used for rating the severity of depressive symptoms. Possible scores range from 0 to 50, with higher scores indicating greater severity of depression.
Measured: Baseline, 4 weeks, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start2 Aug 2023
- Primary completion15 Jul 2026
- Study completion6 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Florida State University
- Responsible party
- Principal investigator, Mohit Chauhan, M.B.B.S., Mayo Clinic
- Investigators
- Mohit Chauhan, MBBS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910957
- Sponsor's protocol ID
- 23-002931
- Status last verified
- Jul 2026
- First submitted
- 11 Jun 2023
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Omic, Clinomic and Digitomic Attributes of Major Depression for Integrative Analytics: the MACADAMIA Pilot Study
- ClinicalTrials.gov ID
- NCT05910957
- Acronym / sponsor ID
- 23-002931
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Florida State University
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 6 Dec 2027 (estimated)
- First posted
- 20 Jun 2023 (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 purpose of this research is to see if information from blood and data from smartwatches can be combined to help diagnose depression and determine if transitions between active depression and treated depression can be predicted.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-depressed controls | – | –Subjects without depression will fill out questionnaires about their general health and wellbeing, quality of life, mental health, emotional health, suicide risk, support system, and childhood experiences. Smartwatch data will also be collected to monitor step count, sleep quality, heart rate (resting and active), and activity rates. |
| Antidepressant-treated adults | – | –Subjects diagnosed with depression will fill out questionnaires about their general health and wellbeing, quality of life, mental health, emotional health, suicide risk, support system, and childhood experiences. Smartwatch data will also be collected to monitor step count, sleep quality, heart rate (resting and active), and activity rates. |
Who may qualify
- Ages
- 20 to 62 years
- Sex
- All
- Age groups
- Adult
- Study population
- 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)
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Quick Inventory of Depressive Symptoms-Clinician Rated (QIDS-CR) scale
Time frame: Baseline, 4 weeks, and 8 weeks
The Quick Inventory of Depressive Symptoms-Clinician Rated is used for rating the severity of depressive symptoms. Possible scores range from 0 to 27, with higher scores indicating greater severity of depression.
1 secondary outcome
Change in Hamilton Depression Rating Scale
Time frame: Baseline, 4 weeks, and 8 weeks
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 16 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mohit Chauhan, MBBS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Unipolar, Non-psychotic Major Depressive Disorder, run by Mayo Clinic 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 5 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quick Inventory of Depressive Symptoms-Clinician Rated (QIDS-CR) scale (time frame: Baseline, 4 weeks, and 8 weeks). 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 16 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.