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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical decision tool | Experimental | Launch of clinical decision support tool at baseline visit with study clinician. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical decision support tool | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Observed clinical outcomes compared to predicted outcome at 2 week follow up | Evaluate the degree of statistical concordance between observed clinical outcomes (non-response/remission) after 8 weeks of treatment and the outcomes predicted by an AHI-based clinical decision support tool after 2 weeks of follow up (i.e., concordance between 2-week predicted outcome and 8-week observed outcome), as assessed using the QIDS-SR and QIDS-CR, in adults with DSM-5-defined MDD who receive prospective treatment with an SSRI or SNRI antidepressant. | Baseline to 2 week visit |
| Measure | Description | Time Frame |
|---|---|---|
| Observed clinical outcomes compared to predicted outcome at 4 week follow up | Evaluate the degree of statistical concordance between observed clinical outcomes (non-response/remission) after 8 weeks of treatment and the outcomes predicted by an AHI-based clinical decision support tool after 4 weeks of follow up (i.e., concordance between 4-week predicted outcome and 8-week observed outcome), as assessed using the QIDS-SR and QIDS-CR, in adults with DSM-5-defined MDD who receive prospective treatment with an SSRI or SNRI antidepressant. |
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Recruitment by invitation only
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William V Bobo, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States | ||
| Mayo Clinic in Rochester |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 7, 2019 | Mar 10, 2020 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 1, 2019 | Mar 10, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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|
| Baseline to 4 week visit |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| D001523 |
| Mental Disorders |