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Completed

NCT Number: NCT04655924

Artificial Intelligence in Depression - Medication Enhancement

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical decision support system

Device

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

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Aifred Health

Industry

Collaborators

  • McGill University

Registry information

Official study 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

Acronym: AID-ME

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 7, 2020
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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