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Augmented Human Intelligence in Major Depressive Disorder

NCT04355650 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2022-12-12

No results posted yet for this study

Summary

Researchers are testing whether a computer program (called a clinical decision support tool) can help clinicians predict how a patient with depression will respond to antidepressant medication.

Conditions

Interventions

OTHER

Clinical decision support tool

Adults (aged 18-64 years) who meet DSM-5 diagnostic criteria for non-psychotic unipolar major depressive disorder (MDD) and meet study eligibility criteria will receive 8 weeks of open-label treatment with an SSRI or SNRI antidepressant. Depressive symptoms will be assessed using the subject- and clinician-rated versions of the 16-items QIDS scale (QIDS-SR and QIDS-CR) and the 17-item HAMD at baseline, week 2 (via telephone), week 4, and week 8; with an additional phone contact at week 24. The QIDS scale scores at 2- and 4-weeks will be entered into the AHI-based clinical decision support tool, and the outcome predicted by the tool (e.g., the predicted eventual treatment outcome at 8 weeks) will be recorded. Clinicians and patients will be blinded to the clinical decision support tool prediction of outcome provided at the 2- and 4 weeks.

Sponsors & Collaborators

Principal Investigators

  • William V Bobo, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-27
Primary Completion
2022-12-02
Completion
2022-12-02

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04355650 on ClinicalTrials.gov