An observational study in Major Depression and Dysthymia, sponsored by OM1, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-18.
Sponsored by OM1, Inc. · Observational
Working with a health system, the investigators will recruit practices to participate in the pilot study, consent and enroll patients with major depressive disorder, and collect the PHQ-9 from those patients at three timepoints (baseline, 6 months post-enrollment, and 12 months post-enrollment). The PHQ-9 will be captured either at an office visit or directly from patients. The investigators will build and implement an open-source SMART on FHIR app to collect key data from the EHR, combine that data with the PHQ-9 results, and present the measurements back to the clinicians. The investigators will then obtain feedback from clinicians on the value and usefulness of the app.
The study is a longitudinal, observational pilot study that will assess the utility and value displaying the harmonized outcomes data to clinicians in the clinical workflow using an open-source, SMART on FHIR app. The app will connect with the site EHR, aggregate EHR and PRO data, calculate the outcome measure results, and return the results to the EHR so that they are viewable within the clinician workflow. Baseline data on patient characteristics, treatments, and symptoms will be combined with longitudinal data on outcomes during the study timeframe. All data will be collected from institution electronic medical records (EMRs), PRO portals, and other existing data sources, as needed.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 5 is below the median of 160 across 1,084 observational studies indexed under Depression.
Browse Depression studies →OM1, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The study will collect data on approximately 50 patients with a diagnosis of major depression or dysthymia from a total of five practices within the same health system.
Exclusion Criteria:
This is an observational study where outcome measures will be extracted from patients' medical records and from questionnaires to provide information back to the clinician.
Death from suicide
Patient age 18 or older with a diagnosis of major depression or dysthymia who died from suicide, reported in 12-month intervals.
Time frame: 12-month intervals
Improvement in Depressive Symptoms: Remission
Patient Health Questionnaire-9 score \> 9 who demonstrates remission defined as a Patient Health Questionnaire-9 score less than 5. Patient Health Questionnaire scores range from 0 to 27. A higher score means more severe depression.
Time frame: Baseline
Improvement in Depressive Symptoms: Remission
Patient Health Questionnaire-9 score \> 9 who demonstrates remission defined as a Patient Health Questionnaire-9 score less than 5. Patient Health Questionnaire scores range from 0 to 27. A higher score means more severe depression.
Time frame: 6 months post baseline (+/- 60 days)
Improvement in Depressive Symptoms: Remission
Patient Health Questionnaire-9 score \> 9 who demonstrates remission defined as a Patient Health Questionnaire-9 score less than 5. Patient Health Questionnaire scores range from 0 to 27. A higher score means more severe depression.
Time frame: 12 months post baseline (+/- 60 days)
Improvement in Depressive Symptoms: Response
Patient age 18 or older with a diagnosis of major depression or dysthymia and an initial Patient Health Questionnaire-9 score \> 9 who demonstrates a response to treatment defined as a Patient Health Questionnaire-9 score that is reduced by 50% or greater from the initial Patient Health Questionnaire-9 score. Patient Health Questionnaire scores range from 0 to 27. A higher score means more severe depression.
Time frame: Baseline
Improvement in Depressive Symptoms: Response
Patient age 18 or older with a diagnosis of major depression or dysthymia and an initial Patient Health Questionnaire-9 score \> 9 who demonstrates a response to treatment defined as a Patient Health Questionnaire-9 score that is reduced by 50% or greater from the initial Patient Health Questionnaire-9 score. Patient Health Questionnaire scores range from 0 to 27. A higher score means more severe depression.
Time frame: 6 months post baseline (+/- 60 days)
Improvement in Depressive Symptoms: Response
Patient age 18 or older with a diagnosis of major depression or dysthymia and an initial Patient Health Questionnaire-9 score \> 9 who demonstrates a response to treatment defined as a Patient Health Questionnaire-9 score that is reduced by 50% or greater from the initial Patient Health Questionnaire-9 score. Patient Health Questionnaire scores range from 0 to 27. A higher score means more severe depression.
Time frame: 12 months post baseline (+/- 60 days)
Worsening in Depressive Symptoms: Recurrence
Patient age 18 or older with a diagnosis of major depression or dysthymia and an initial Patient Health Questionnaire-9 \> 9 who demonstrates remission (defined as a Patient Health Questionnaire-9 score \< 5) of at least two months' duration and subsequently experiences a recurrence of a depressive episode, defined as a Patient Health Questionnaire-9 score \> 9 OR hospitalization for depression or suicidality. Patient Health Questionnaire scores range from 0 to 27. A higher score means more severe depression.
Time frame: Baseline
Worsening in Depressive Symptoms: Recurrence
Patient age 18 or older with a diagnosis of major depression or dysthymia and an initial Patient Health Questionnaire-9 \> 9 who demonstrates remission (defined as a Patient Health Questionnaire-9 score \< 5) of at least two months' duration and subsequently experiences a recurrence of a depressive episode, defined as a Patient Health Questionnaire-9 score \> 9 OR hospitalization for depression or suicidality. Patient Health Questionnaire scores range from 0 to 27. A higher score means more severe depression.
Time frame: 6 months post baseline (+/- 60 days)
Worsening in Depressive Symptoms: Recurrence
Patient age 18 or older with a diagnosis of major depression or dysthymia and an initial Patient Health Questionnaire-9 \> 9 who demonstrates remission (defined as a Patient Health Questionnaire-9 score \< 5) of at least two months' duration and subsequently experiences a recurrence of a depressive episode, defined as a Patient Health Questionnaire-9 score \> 9 OR hospitalization for depression or suicidality. Patient Health Questionnaire scores range from 0 to 27. A higher score means more severe depression.
Time frame: 12 months post baseline (+/- 60 days)
Adverse Events
Depression treatment-related adverse events, captured using the Frequency, Intensity, and Burden of Side Effects Ratings scale where available and extracted from data routinely recorded in the Electronic Medical Record. The Frequency, Intensity, and Burden of Side Effects Ratings score ranges from 0 to 6. A higher score means more of a burden.
Time frame: Baseline
Adverse Events
Depression treatment-related adverse events, captured using the Frequency, Intensity, and Burden of Side Effects Ratings scale where available and extracted from data routinely recorded in the Electronic Medical Record. The Frequency, Intensity, and Burden of Side Effects Ratings score ranges from 0 to 6. A higher score means more of a burden.
Time frame: 6 months post baseline (+/- 60 days)
Adverse Events
Depression treatment-related adverse events, captured using the Frequency, Intensity, and Burden of Side Effects Ratings scale where available and extracted from data routinely recorded in the Electronic Medical Record. The Frequency, Intensity, and Burden of Side Effects Ratings score ranges from 0 to 6. A higher score means more of a burden.
Time frame: 12 months post baseline (+/- 60 days)
Suicide Ideation and Behavior
Selection of 'several days', 'more than half the days' or 'nearly every day' option on Patient Health Questionnaire-9 item 9 ("Thoughts that you would be better off dead or of hurting yourself in some way") and/or documentation of nonfatal suicide attempts/suicide attempt behaviors, planning/preparatory acts, or active suicidal ideation extracted from data routinely recorded in the Electronic Medical Record. A higher score means more severe depression.
Time frame: Baseline
Suicide Ideation and Behavior
Selection of 'several days', 'more than half the days' or 'nearly every day' option on Patient Health Questionnaire-9 item 9 ("Thoughts that you would be better off dead or of hurting yourself in some way") and/or documentation of nonfatal suicide attempts/suicide attempt behaviors, planning/preparatory acts, or active suicidal ideation extracted from data routinely recorded in the Electronic Medical Record. A higher score means more severe depression.
Time frame: 6 months post baseline (+/- 60 days)
Suicide Ideation and Behavior
Selection of 'several days', 'more than half the days' or 'nearly every day' option on Patient Health Questionnaire-9 item 9 ("Thoughts that you would be better off dead or of hurting yourself in some way") and/or documentation of nonfatal suicide attempts/suicide attempt behaviors, planning/preparatory acts, or active suicidal ideation extracted from data routinely recorded in the Electronic Medical Record. A higher score means more severe depression.
Time frame: 12 months post baseline (+/- 60 days)
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OM1, Inc.