Artificial Intelligence in Depression - Medication Enhancement (AID-ME)

• ClinicalTrials.gov Identifier: NCT04655924
• Recruitment Status: Not yet recruiting
• First Posted: December 7, 2020
• Last Update Posted: February 11, 2022
• Sponsor: Aifred Health
• Collaborators: Stiris Research; McDougall Scientific; McGill University
• Information provided by (Responsible Party): Aifred Health, Aifred Health Inc.

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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated 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.
• 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
• Estimated Study Start Date: February 2022
• Estimated Primary Completion Date: October 2022
• Estimated Study Completion Date: October 2022

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Time to Remission [ Time Frame: 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.
2. Response Rate [ Time Frame: 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.
3. Patient Disability with WHODAS rating scale [ Time Frame: 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:

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

United States, Connecticut

Yale University, VA Connecticut Healthcare System

West Haven, Connecticut, United States, 06516

Contact: Kimberlee Forselius-Bielen, BS 203-974-7540 kimberlee.forselius@yale.edu

Principal Investigator: Mohini Ranganathan, MD

United States, Florida

Sarkis Clinical Trials, Inc.

Gainesville, Florida, United States, 32607

Contact: Elias Sarkis, MD 352-333-0094 mwaters@ehsfamily.com

South Florida Veterans Affairs

Miami, Florida, United States, 33125

Contact: Maria Umbert, MD 305-575-3431 maria.umbert@va.gov

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30322

Contact: Boadie Dunlop, MD 404-712-2000 bdunlop@emory.edu

United States, Michigan

University of Michigan, Michigan Medicine

Ann Arbor, Michigan, United States, 48109

Contact: Sagar V Parikh, MD 734-936-4000 parikhsa@med.umich.edu

United States, Virginia

Salem VAMC

Salem, Virginia, United States, 24153

Contact: Mamta Sapra, MD 540-982-2463 ext 1207 mamta.sapra@va.gov

Canada, Alberta

Mathison Centre for Mental Health Research & Education - Hotchkiss Brain Institute

Calgary, Alberta, Canada, T2N4Z6

Contact: Thomas Raedler, MD 403-210-6899 thomas.raedler@albertahealthservices.ca

Canada, Ontario

CAMH: The Centre for Addiction and Mental Health

Toronto, Ontario, Canada, M6J1H4

Contact: Stefan Kloiber, MD 416-535-8501 stefan.kloiber@camh.ca

Canada, Quebec

CIUSSS de l'Est-de-l'Île-de-Montréal

Montréal, Quebec, Canada, H1N3V2

Contact: Valérie Tourjman, MD 514-251-4000 ext 3696 vtourjman.iusmm@sss.gouv.qc.ca

CIUSSS De Centre Ouest De L'île de Montréal

Montréal, Quebec, Canada, H3T1E2

Contact: Karl Looper, MD 514-340-8222 karl.looper.med@sss.gouv.qc.ca

McGill University Health Care Centre (MUHC)

Montréal, Quebec, Canada, H4A3J1

Contact: Howard Margolese, MD 514-934-1934 howard.margolese@mcgill.ca

GMF Centre Médical Métro Monk

Montréal, Quebec, Canada, H4E2L5

Contact: Mimi Israel, MD 514-769-9999 isrmim@douglas.mcgill.ca

CIUSSS De L'Ouest de L'île de Montréal

Montréal, Quebec, Canada, H4H1R3

Contact: Anthony J Gifuni, MD 514-761-6131 ext 3317 anthony.gifuni@mcgill.ca

Douglas Mental Health University Institute

Verdun, Quebec, Canada, H4H 1R3

Contact: David Benrimoh, MD, CM, MSc 514-463-7813 david.benrimoh@mail.mcgill.ca

Principal Investigator: Gustavo Turecki, MD, PhD

Principal Investigator: Howard Margolese, MD, CM, MSc

Sub-Investigator: David Benrimoh, MD, CM, MSc

Sub-Investigator: Myriam Tanguay-Sela, BA&Sc

Sub-Investigator: Colleen Rollins, BSc

Sub-Investigator: Sonia Israel, BSc

Sub-Investigator: Christina Popescu, MSc, BA&Sc

Sponsors and Collaborators

Aifred Health

Stiris Research

McDougall Scientific

McGill University

More Information

• Responsible Party: Aifred Health, Clinical Trial Coordinator, Aifred Health Inc.
• ClinicalTrials.gov Identifier: NCT04655924
• Other Study ID Numbers: IUSMD 18-04
• First Posted: December 7, 2020
• Last Update Posted: February 11, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: With participating site and on request. Further sharing will be determined at a later date.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: To be determined.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Aifred Health, Aifred Health Inc.:

Depression; Treatment Selection; Decision Support; Artificial Intelligence (AI); Machine Learning (ML)

Additional relevant MeSH terms:

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders