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

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Clinical Decision Support System
Sponsored by
Aifred Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Treatment Selection, Decision Support, Artificial Intelligence (AI), Machine Learning (ML)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • VA New Haven, VA Connecticut Healthcare SystemRecruiting
  • South Florida Veterans Affairs
  • Emory UniversityRecruiting
  • University of Michigan, Michigan MedicineRecruiting
  • Salem VAMCRecruiting
  • CAMH: The Centre for Addiction and Mental HealthRecruiting
  • CIUSSS de l'Est-de-l'Île-de-Montréal
  • CIUSSS De Centre Ouest De L'île de MontréalRecruiting
  • McGill University Health Care Centre (MUHC)Recruiting
  • CIUSSS De L'Ouest de L'île de MontréalRecruiting
  • Douglas Mental Health University InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active Intervention

Active Control

Arm Description

Intervention delivered to patients by digital health platform.

Intervention delivered to patients by digital health platform.

Outcomes

Primary Outcome Measures

Rate of Safety - Adverse Events
Adverse and Serious Adverse Events
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.

Secondary Outcome Measures

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.
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.
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).

Full Information

First Posted
November 23, 2020
Last Updated
March 23, 2023
Sponsor
Aifred Health
Collaborators
McGill University
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1. Study Identification

Unique Protocol Identification Number
NCT04655924
Brief Title
Artificial Intelligence in Depression - Medication Enhancement
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aifred Health
Collaborators
McGill University

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Treatment Selection, Decision Support, Artificial Intelligence (AI), Machine Learning (ML)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
Patient and Rater blinded, Physician partially blinded
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Intervention
Arm Type
Experimental
Arm Description
Intervention delivered to patients by digital health platform.
Arm Title
Active Control
Arm Type
Active Comparator
Arm Description
Intervention delivered to patients by digital health platform.
Intervention Type
Device
Intervention Name(s)
Clinical Decision Support System
Intervention Description
Clinical Decision Support System using Measurement-Based Care and Digital Decision Support Platform
Primary Outcome Measure Information:
Title
Rate of Safety - Adverse Events
Description
Adverse and Serious Adverse Events
Time Frame
3 months
Title
Effectiveness in Reduction of Depression Symptoms
Description
This is approved as a physician partially-blinded study and, as such, physicians are blinded to the primary outcome.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Time to Remission
Description
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.
Time Frame
3 months
Title
Response Rate
Description
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.
Time Frame
3 months
Title
Patient Disability with WHODAS rating scale
Description
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).
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Number of ER visits, admissions, and re-admissions
Description
We will examine impact of health resource utilization by comparing rates of visits, admissions, and re-admissions between groups.
Time Frame
3 months
Title
Medication Adherence Rates
Description
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.
Time Frame
3 months
Title
Patient Questionnaire Response Rate
Description
We will assess the frequency at which patients complete the questionnaires in the digital health platform in both groups.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
VA New Haven, VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Moricz
Phone
203-932-5711
Ext
4485
Email
maria.moricz@yale.edu
Facility Name
South Florida Veterans Affairs
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Umbert, MD
Phone
305-575-3431
Email
maria.umbert@va.gov
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boadie Dunlop, MD
Phone
404-712-2000
Email
bdunlop@emory.edu
Facility Name
University of Michigan, Michigan Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sagar V Parikh, MD
Phone
734-936-4000
Email
parikhsa@med.umich.edu
Facility Name
Salem VAMC
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mamta Sapra, MD
Phone
540-982-2463
Ext
1207
Email
mamta.sapra@va.gov
Facility Name
CAMH: The Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J1H4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Kloiber, MD
Phone
416-535-8501
Email
stefan.kloiber@camh.ca
Facility Name
CIUSSS de l'Est-de-l'Île-de-Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1N3V2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georges Pinard, MD
Email
georges.pinard.med@ssss.gouv.qc.ca
Facility Name
CIUSSS De Centre Ouest De L'île de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T1E2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karl Looper, MD
Phone
514-340-8222
Email
karl.looper.med@sss.gouv.qc.ca
Facility Name
McGill University Health Care Centre (MUHC)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Howard Margolese, MD
Phone
514-934-1934
Email
howard.margolese@mcgill.ca
Facility Name
CIUSSS De L'Ouest de L'île de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4H1R3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony J Gifuni, MD
Phone
514-761-6131
Ext
3317
Email
anthony.gifuni@mcgill.ca
Facility Name
Douglas Mental Health University Institute
City
Verdun
State/Province
Quebec
ZIP/Postal Code
H4H 1R3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Benrimoh, MD, CM, MSc
Phone
514-463-7813
Email
david.benrimoh@mail.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Anthony Gifuni, MD, PhD
First Name & Middle Initial & Last Name & Degree
David Benrimoh, MD, CM, MSc
First Name & Middle Initial & Last Name & Degree
Myriam Tanguay-Sela, BA&Sc
First Name & Middle Initial & Last Name & Degree
Colleen Rollins, BSc
First Name & Middle Initial & Last Name & Degree
Sonia Israel, BSc
First Name & Middle Initial & Last Name & Degree
Christina Popescu, MSc, BA&Sc

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
With participating site and on request. Further sharing will be determined at a later date.
IPD Sharing Time Frame
To be determined.

Learn more about this trial

Artificial Intelligence in Depression - Medication Enhancement

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