Clinical trial NCT04655924: Artificial Intelligence in Depression - Medication Enhancement
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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Treatment Selection
Decision Support
Artificial Intelligence (AI)
Machine Learning (ML)
Lead sponsor: Aifred Health Inc.
Sponsor class: INDUSTRY
Collaborators: name: McGill University
First posted: 2020-12-07
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Rate of Safety - Adverse Events
timeFrame: 3 months
measure: Effectiveness in Reduction of Depression Symptoms
timeFrame: 3 months
Secondary outcomes:
measure: Time to Remission
timeFrame: 3 months
measure: Response Rate
timeFrame: 3 months
measure: Patient Disability with WHODAS rating scale
timeFrame: 3 months
Other outcomes:
measure: Number of ER visits, admissions, and re-admissions
timeFrame: 3 months
measure: Medication Adherence Rates
timeFrame: 3 months
measure: Patient Questionnaire Response Rate
timeFrame: 3 months
Locations:
city: West Haven
country: United States
facility: VA New Haven, VA Connecticut Healthcare System
state: Connecticut
city: Miami
country: United States
facility: South Florida Veterans Affairs
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan, Michigan Medicine
state: Michigan
city: Salem
country: United States
facility: Salem VAMC
state: Virginia
city: Toronto
country: Canada
facility: CAMH: The Centre for Addiction and Mental Health
state: Ontario
city: Montréal
country: Canada
facility: CIUSSS de l'Est-de-l'Île-de-Montréal
state: Quebec
city: Montréal
country: Canada
facility: CIUSSS De Centre Ouest De L'île de Montréal
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Care Centre (MUHC)
state: Quebec
city: Montréal
country: Canada
facility: CIUSSS De L'Ouest de L'île de Montréal
state: Quebec
city: Verdun
country: Canada
facility: Douglas Mental Health University Institute
state: Quebec
Study officials:
References: