NCT Number: NCT04235725
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.
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Notify Me18 year and older
All sexes
Observational
American Psychiatric Association, Washington D.C., District of Columbia, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 12-month intervals
Patient age 18 or older with a diagnosis of major depression or dysthymia who died from suicide.
Time frame: Baseline
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)
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)
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
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: 6 months post baseline (+/- 60 days)
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)
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
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)
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)
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
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)
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)
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
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)
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)
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.
OM1, Inc.
Industry
Implementation of Harmonized Depression Outcome Measures in a Primary Care Registry and a Mental Health Registry to Support Patient-Centered Outcomes Research
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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