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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04655924
Recruitment Status : Not yet recruiting
First Posted : December 7, 2020
Last Update Posted : February 11, 2022
Sponsor:
Collaborators:
Stiris Research
McDougall Scientific
McGill University
Information provided by (Responsible Party):
Aifred Health, Aifred Health Inc.

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

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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

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04655924


Locations
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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
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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    Key Record Dates
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.

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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:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders