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| Name | Class |
|---|---|
| McGill University | OTHER |
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This study will determine the safety and potential effectiveness of a digital health platform aimed at improving treatment outcomes for patients with depression by assisting physicians with clinical decision making about depression treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Intervention | Experimental | Intervention delivered to patients by digital health platform. |
|
| Active Control | Active Comparator | Intervention delivered to patients by digital health platform. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Decision Support System | Device | Clinical Decision Support System using Measurement-Based Care and Digital Decision Support Platform |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Safety - Adverse Events | Adverse and Serious Adverse Events | 3 months |
| Effectiveness in Reduction of Depression Symptoms | This is approved as a physician partially-blinded study and, as such, physicians are blinded to the primary outcome. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Remission | To evaluate time to remission between groups. The hypothesis is that time to remission will be shorter in the active intervention group compared to the active control group. | 3 months |
| Response Rate |
| Measure | Description | Time Frame |
|---|---|---|
| Number of ER visits, admissions, and re-admissions | We will examine impact of health resource utilization by comparing rates of visits, admissions, and re-admissions between groups. | 3 months |
| Medication Adherence Rates |
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Physician Inclusion Criteria:
No Physician Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA New Haven, VA Connecticut Healthcare System | West Haven | Connecticut | 06516 | United States | ||
| South Florida Veterans Affairs |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40875536 | Derived | Benrimoh D, Whitmore K, Richard M, Golden G, Perlman K, Jalali S, Friesen T, Barkat Y, Mehltretter J, Fratila R, Armstrong C, Israel S, Popescu C, Karp JF, Parikh SV, Golchi S, Moodie EEM, Shen J, Gifuni AJ, Ferrari M, Sapra M, Kloiber S, Pinard GF, Dunlop BW, Looper K, Ranganathan M, Enault M, Beaulieu S, Rej S, Hersson-Edery F, Steiner W, Anacleto A, Qassim S, McGuire-Snieckus R, Margolese HC. Artificial Intelligence in Depression-Medication Enhancement (AID-ME): A Cluster Randomized Trial of a Deep-Learning-Enabled Clinical Decision Support System for Personalized Depression Treatment Selection and Management. J Clin Psychiatry. 2025 Aug 27;86(3):24m15634. doi: 10.4088/JCP.24m15634. |
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With participating site and on request. Further sharing will be determined at a later date.
To be determined.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 21, 2024 | Jan 15, 2025 | 8 | ||
| Jan 30, 2025 |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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The Clinical Decision Aid is a digital health platform that collects patient data and provides reports and analyses to clinicians that can assist them in their decision making about treatment selection and management.
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Patient and Rater blinded, Physician partially blinded
To evaluate response rate between groups. The hypothesis is that the response rate (defined as 50% improvement in symptoms) and time to response, will be higher and lower, respectively, in the active intervention group compared to the active control group.
| 3 months |
| Patient Disability with WHODAS rating scale | To evaluate between-group differences in patient disability outcomes. The hypothesis is that the physicians in the active intervention arm will produce superior patient outcomes to those physicians using usual guideline-informed practice, in terms of patient function as measured by a rating scale (WHODAS). | 3 months |
We will asses medication adherence rates, as measured by the Brief Adherence Rating Scale, after each visit for the duration of the study and compare between groups.
| 3 months |
| Patient Questionnaire Response Rate | We will assess the frequency at which patients complete the questionnaires in the digital health platform in both groups. | 3 months |
| Miami |
| Florida |
| 33125 |
| United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| University of Michigan, Michigan Medicine | Ann Arbor | Michigan | 48109 | United States |
| Salem VAMC | Salem | Virginia | 24153 | United States |
| CAMH: The Centre for Addiction and Mental Health | Toronto | Ontario | M6J1H4 | Canada |
| CIUSSS de l'Est-de-l'Île-de-Montréal | Montreal | Quebec | H1N3V2 | Canada |
| CIUSSS De Centre Ouest De L'île de Montréal | Montreal | Quebec | H3T1E2 | Canada |
| McGill University Health Care Centre (MUHC) | Montreal | Quebec | H4A3J1 | Canada |
| CIUSSS De L'Ouest de L'île de Montréal | Montreal | Quebec | H4H1R3 | Canada |
| Douglas Mental Health University Institute | Verdun | Quebec | H4H 1R3 | Canada |
| Feb 19, 2025 |
| 9 |