Artificial Intelligence in Depression - Medication Enhancement

Not Applicable

Completed

• Conditions: Depression

• Registration Number: NCT04655924
• Lead Sponsor: Aifred Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-23
• Study First Submitted QC: 2020-11-30
• Study First Posted: 2020-12-07
• Study Start: 2022-06-16
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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.

Trial Locations

Locations (11)

VA New Haven, VA Connecticut Healthcare System; 🇺🇸 West Haven, Connecticut, United States

South Florida Veterans Affairs; 🇺🇸 Miami, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

University of Michigan, Michigan Medicine; 🇺🇸 Ann Arbor, Michigan, United States

Salem VAMC; 🇺🇸 Salem, Virginia, United States

CAMH: The Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada

CIUSSS de l'Est-de-l'Île-de-Montréal; 🇨🇦 Montréal, Quebec, Canada

CIUSSS De Centre Ouest De L'île de Montréal; 🇨🇦 Montréal, Quebec, Canada

McGill University Health Care Centre (MUHC); 🇨🇦 Montréal, Quebec, Canada

CIUSSS De L'Ouest de L'île de Montréal; 🇨🇦 Montréal, Quebec, Canada

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