Implementation of Harmonized Depression Outcome Measures in a Primary Care Registry and a Mental Health Registry

Major Depression Clinical Trial

Official title: Implementation of Harmonized Depression Outcome Measures in a Primary Care Registry and a Mental Health Registry to Support Patient-Centered Outcomes Research

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Dysthymia
• Major Depression

• NCT number: NCT04235725
• Study type: Observational [Patient Registry]
• Source: OM1, Inc.
• Status: Completed
• Start date: March 15, 2020
• Completion date: May 15, 2021