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

NCT04235725 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • OTHER Harmonized Depression Outcome Measures

Study Locations (2)

District of Columbia

  • American Psychiatric Association — Washington D.C.

Kentucky

  • American Board of Family Medicine — Lexington

Trial Details

FieldValue
Enrollment Target 953 participants
Start Date 2020-03-15
Est. Completion 2021-05-15

Sponsor

OM1

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04235725

The ClinicalTrials.gov registry entry for NCT04235725 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 953 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OM1, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Major Depression appearing as the primary indexed condition, and to 1 intervention — of which Harmonized Depression Outcome Measures is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04235725 reports 2 study locations spanning 2 distinct geographic areas — top geographies include District of Columbia, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04235725 about?

NCT04235725 is a clinical study titled "Implementation of Harmonized Depression Outcome Measures in a Primary Care Registry and a Mental Health Registry". 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.

What is the current status of trial NCT04235725?

This trial is currently completed. The enrollment target is 953 participants. The study started on 2020-03-15. Estimated completion is 2021-05-15.

What conditions does trial NCT04235725 study?

This clinical trial studies the following conditions: Major Depression, Dysthymia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04235725?

The interventions under investigation include: Harmonized Depression Outcome Measures (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04235725?

This trial is sponsored by OM1, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04235725 being conducted?

This trial has 2 study locations across District of Columbia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial