The purpose of this pilot project is to demonstrate feasibility and value of collecting harmonized outcomes measures for major depressive disorder (MDD) in two registries and combining the data to support patient-centered outcomes research.
The study is a longitudinal, multi-center observational feasibility study that will include data on eligible patients with a diagnosis of major depressive disorder (MDD). Retrospective data on previous disease status and patient characteristics will be collected and combined with longitudinal data from these data sources 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. Two registries (PsychPRO and the PRIME Registry) will participate in this feasibility study. A total of 20 sites participating in the registries (10 from each registry) will be recruited to participate in this study. To participate, sites must see adult patients with major depression or dysthymia and be willing to collect the PHQ-9 on a regular basis. Sites will have the option of using the Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) scale to capture information on adverse events, but use of the FIBSER is not required.
Study Type
OBSERVATIONAL
Enrollment
953
This is an observational study where retrospective data on previous disease status and patient characteristics will be collected and combined with longitudinal data from these data sources on outcomes during the study timeframe.
American Psychiatric Association
Washington D.C., District of Columbia, United States
American Board of Family Medicine
Lexington, Kentucky, United States
Death from suicide
Patient age 18 or older with a diagnosis of major depression or dysthymia who died from suicide.
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.
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.
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.
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.
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.
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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.
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.
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.
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.
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 EMR. The Frequency, Intensity, and Burden of Side Effects Ratings score ranges from 0 to 6.
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 EMR. The Frequency, Intensity, and Burden of Side Effects Ratings score ranges from 0 to 6.
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 EMR. The Frequency, Intensity, and Burden of Side Effects Ratings score ranges from 0 to 6.
Time frame: 12 months post baseline (+/- 60 days)
Suicide Ideation and Behavior 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.
Time frame: Baseline
Suicide Ideation and Behavior 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.
Time frame: 6 months post baseline (+/- 60 days)
Suicide Ideation and Behavior 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.
Time frame: 12 months post baseline (+/- 60 days)