Artificial Intelligence in Depression - Medication Enhancement

Depression Clinical Trial

— AID-ME  

Official title:

Artificial Intelligence in Depression - Medication Enhancement: A Randomized, Patient and Rater Blinded, Active-Controlled Trial of a Hybrid-Classic/Machine-Learning Enabled Clinical Decision Aid for Personalized and Individualized Pharmacological Depression Treatment Selection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04655924
• Other study ID #: IUSMD 18-04
• Status: Completed
• Phase: N/A
• Start date: June 16, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Aifred Health Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Patient Inclusion Criteria:

• diagnosed with major depressive disorder by a physician using DSM-V criteria

• able to provide informed consent

• patients must confirm that they are comfortable being treated for depression by their physician, who may propose a range of treatment options, such as medications or psychotherapies, consistent with best practice guidelines for depression which are included in the application. Physicians will be required, as in usual practice, to explain treatments to patients and patients will be able to give and withdraw consent for treatment in general or for specific treatments as in usual practice.

Patient Exclusion Criteria:

• bipolar disorder of any type

• inability or unwillingness of the individual to give informed consent

• inability to manage patient in an outpatient setting (i.e. imminent suicidality)

• active major depression is not the main condition being treated (i.e. the patient has depressive symptoms in the context of severe substance abuse or a psychotic disorder, but a primary diagnosis of major depressive episode (MDE) cannot be made or would result in inappropriate care).

• inability to use the tool (i.e. patient cannot interface with a mobile phone or computer due to delirium, or another medical condition)* *Note that for patients who do not have access to mobile or desktop devices but are able to use them or to be trained to use them, these will be provided to them at no cost.

Physician Inclusion Criteria:

• any family doctor/primary care physician or psychiatrist accredited in Canada or the USA who treats patients with depression on at least a monthly basis, as well as residents from these specialities supervised by a participating physician

• able to provide informed consent

• comfortable prescribing the range of potential treatments which could have probabilities provided for them by the CDA

No Physician Exclusion Criteria

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Clinical Decision Support System
Clinical Decision Support System using Measurement-Based Care and Digital Decision Support Platform

Locations

Country	Name	City	State
Canada	CIUSSS De Centre Ouest De L'île de Montréal	Montréal	Quebec
Canada	CIUSSS de l'Est-de-l'Île-de-Montréal	Montréal	Quebec
Canada	CIUSSS De L'Ouest de L'île de Montréal	Montréal	Quebec
Canada	McGill University Health Care Centre (MUHC)	Montréal	Quebec
Canada	CAMH: The Centre for Addiction and Mental Health	Toronto	Ontario
Canada	Douglas Mental Health University Institute	Verdun	Quebec
United States	University of Michigan, Michigan Medicine	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	South Florida Veterans Affairs	Miami	Florida
United States	Salem VAMC	Salem	Virginia
United States	VA New Haven, VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Aifred Health	McGill University

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Medication Adherence Rates	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
Other	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
Primary	Rate of Safety - Adverse Events	Adverse and Serious Adverse Events	3 months
Primary	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
Secondary	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
Secondary	Response Rate	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
Secondary	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