Clinical trial NCT05910957: Multi-Omic, Clinomic and Digitomic Attributes of Major Depression for Integrative Analytics
Official title: Multi-Omic, Clinomic and Digitomic Attributes of Major Depression for Integrative Analytics: the MACADAMIA Pilot Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Major Depressive Disorder
Unipolar, Non-psychotic Major Depressive Disorder
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Florida State University
First posted: 2023-06-20
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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)

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Quick Inventory of Depressive Symptoms-Clinician Rated (QIDS-CR) scale
timeFrame: Baseline, 4 weeks, and 8 weeks
Secondary outcomes:
measure: Change in Hamilton Depression Rating Scale
timeFrame: Baseline, 4 weeks, and 8 weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Mohit Chauhan, MBBS
role: PRINCIPAL_INVESTIGATOR
References: