NCT04235725

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
953

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 15, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

1.2 years

First QC Date

January 7, 2020

Last Update Submit

May 14, 2021

Conditions

Major DepressionDysthymia

Outcome Measures

Primary Outcomes (16)

  • Death from suicide

    Patient age 18 or older with a diagnosis of major depression or dysthymia who died from suicide.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    12 months post baseline (+/- 60 days)

Interventions

Harmonized Depression Outcome MeasuresOTHER

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will collect data on approximately 200 patients with a diagnosis of major depression or dysthymia from a total of 20 sites (10 from each registry).

You may qualify if:

  • Age \>=18 years
  • Diagnosis of major depression or dysthymia as documented in the patient's EMR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

American Psychiatric Association

Washington D.C., District of Columbia, 20024, United States

Location

American Board of Family Medicine

Lexington, Kentucky, 40511, United States

Location

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorDysthymic Disorder

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
14 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 22, 2020

Study Start

March 15, 2020

Primary Completion

May 15, 2021

Study Completion

May 15, 2021

Last Updated

May 18, 2021

Record last verified: 2021-05

Locations

US(2)