Artificial Intelligence in Depression - Medication Enhancement

NCT ID: NCT04655924

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-16

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Patient and Rater blinded, Physician partially blinded

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active Intervention

Intervention delivered to patients by digital health platform.

Group Type EXPERIMENTAL

Clinical Decision Support System

Intervention Type DEVICE

Clinical Decision Support System using Measurement-Based Care and Digital Decision Support Platform

Active Control

Intervention delivered to patients by digital health platform.

Group Type ACTIVE_COMPARATOR

Clinical Decision Support System

Intervention Type DEVICE

Clinical Decision Support System using Measurement-Based Care and Digital Decision Support Platform

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clinical Decision Support System

Clinical Decision Support System using Measurement-Based Care and Digital Decision Support Platform

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.


* 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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

McGill University

OTHER

Sponsor Role collaborator

Aifred Health

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aifred Health

Clinical Trial Manager

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

VA New Haven, VA Connecticut Healthcare System

West Haven, Connecticut, United States

Site Status

South Florida Veterans Affairs

Miami, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

University of Michigan, Michigan Medicine

Ann Arbor, Michigan, United States

Site Status

Salem VAMC

Salem, Virginia, United States

Site Status

CAMH: The Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status

CIUSSS de l'Est-de-l'Île-de-Montréal

Montreal, Quebec, Canada

Site Status

CIUSSS De Centre Ouest De L'île de Montréal

Montreal, Quebec, Canada

Site Status

McGill University Health Care Centre (MUHC)

Montreal, Quebec, Canada

Site Status

CIUSSS De L'Ouest de L'île de Montréal

Montreal, Quebec, Canada

Site Status

Douglas Mental Health University Institute

Verdun, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

References

Explore related publications, articles, or registry entries linked to this study.

Benrimoh D, Whitmore K, Richard M, Golden G, Perlman K, Jalali S, Friesen T, Barkat Y, Mehltretter J, Fratila R, Armstrong C, Israel S, Popescu C, Karp JF, Parikh SV, Golchi S, Moodie EEM, Shen J, Gifuni AJ, Ferrari M, Sapra M, Kloiber S, Pinard GF, Dunlop BW, Looper K, Ranganathan M, Enault M, Beaulieu S, Rej S, Hersson-Edery F, Steiner W, Anacleto A, Qassim S, McGuire-Snieckus R, Margolese HC. Artificial Intelligence in Depression-Medication Enhancement (AID-ME): A Cluster Randomized Trial of a Deep-Learning-Enabled Clinical Decision Support System for Personalized Depression Treatment Selection and Management. J Clin Psychiatry. 2025 Aug 27;86(3):24m15634. doi: 10.4088/JCP.24m15634.

Reference Type DERIVED
PMID: 40875536 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IUSMD 18-04

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.