AID-ME: Artificial Intelligence in Depression - Medication Enhancement

Sponsor

Aifred Health (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04655924

Collaborator

Stiris Research (Other), McDougall Scientific (Other), McGill University (Other)

500

Enrollment

Locations

Arms

8.5

Anticipated Duration (Months)

38.5

Patients Per Site

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Device: Clinical Decision Support System	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Double (Participant, Investigator)

Masking Description:

Patient and Rater blinded, Physician partially blinded

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 16, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active Intervention Intervention delivered to patients by digital health platform.	Device: Clinical Decision Support System Clinical Decision Support System using Measurement-Based Care and Digital Decision Support Platform
Active Comparator: Active Control Intervention delivered to patients by digital health platform.	Device: Clinical Decision Support System Clinical Decision Support System using Measurement-Based Care and Digital Decision Support Platform

Arm

Intervention/Treatment

Experimental: Active Intervention

Intervention delivered to patients by digital health platform.

Device: Clinical Decision Support System

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

Active Comparator: Active Control

Intervention delivered to patients by digital health platform.

Device: Clinical Decision Support System

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

Outcome Measures

Primary Outcome Measures

Rate of Safety - Adverse Events [3 months]
Adverse and Serious Adverse Events
Effectiveness in Reduction of Depression Symptoms [3 months]
This is approved as a physician partially-blinded study and, as such, physicians are blinded to the primary outcome.

Secondary Outcome Measures

Time to Remission [3 months]
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.
Response Rate [3 months]
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.
Patient Disability with WHODAS rating scale [3 months]
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).

Other Outcome Measures

Number of ER visits, admissions, and re-admissions [3 months]
We will examine impact of health resource utilization by comparing rates of visits, admissions, and re-admissions between groups.
Medication Adherence Rates [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.
Patient Questionnaire Response Rate [3 months]
We will assess the frequency at which patients complete the questionnaires in the digital health platform in both groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Florida Veterans Affairs	Miami	Florida	United States	33125
2	Emory University	Atlanta	Georgia	United States	30322
3	University of Michigan, Michigan Medicine	Ann Arbor	Michigan	United States	48109
4	Green Mountain Research Institute	Rutland	Vermont	United States	05701
5	Salem VAMC	Salem	Virginia	United States	24153
6	Mathison Centre for Mental Health Research & Education - Hotchkiss Brain Institute	Calgary	Alberta	Canada	T2N4Z6
7	CAMH: The Centre for Addiction and Mental Health	Toronto	Ontario	Canada	M6J1H4
8	CIUSSS de l'Est-de-l'Île-de-Montréal	Montréal	Quebec	Canada	H1N3V2
9	CIUSSS De Centre Ouest De L'île de Montréal	Montréal	Quebec	Canada	H3T1E2
10	McGill University Health Care Centre (MUHC)	Montréal	Quebec	Canada	H4A3J1
11	GMF Centre Médical Métro Monk	Montréal	Quebec	Canada	H4E2L5
12	CIUSSS De L'Ouest de L'île de Montréal	Montréal	Quebec	Canada	H4H1R3
13	Douglas Mental Health University Institute	Verdun	Quebec	Canada	H4H 1R3