CompletedNot Applicable

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

United States953 participantsStarted 2020-03-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Age \>=18 years * Diagnosis of major depression or dysthymia as documented in the patient's EMR Exclusion Criteria: * There are no exclusion criteria for this study.

What they're measuring

Death from suicide

Timeframe: 12-month intervals

Improvement in Depressive Symptoms: Remission

Timeframe: Baseline

Improvement in Depressive Symptoms: Remission

Timeframe: 6 months post baseline (+/- 60 days)

Improvement in Depressive Symptoms: Remission

Timeframe: 12 months post baseline (+/- 60 days)

Improvement in Depressive Symptoms: Response

Timeframe: Baseline

Improvement in Depressive Symptoms: Response

Timeframe: 6 months post baseline (+/- 60 days)

Improvement in Depressive Symptoms: Response

Timeframe: 12 months post baseline (+/- 60 days)

Worsening in Depressive Symptoms: Recurrence

Timeframe: Baseline

Trial details

NCT IDNCT04235725

SponsorOM1, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-05-15

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