Major Depressive Disorder, Unipolar, Non-psychotic Major Depressive Disorder
Conditions
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.
Interventions
None listed
Sponsors
Mayo Clinic
Florida State University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 62 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quick Inventory of Depressive Symptoms-Clinician Rated (QIDS-CR) scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hamilton Depression Rating Scale | Baseline, 4 weeks, and 8 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMohit Chauhan, MBBS
Mayo Clinic
Outcome results
None listed